Trial Outcomes & Findings for Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants (NCT NCT05791565)
NCT ID: NCT05791565
Last Updated: 2024-09-23
Results Overview
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
|---|---|---|
|
Period 1 (Day 1)
STARTED
|
14
|
14
|
|
Period 1 (Day 1)
COMPLETED
|
14
|
14
|
|
Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (Minimum 72 Hours)
STARTED
|
14
|
14
|
|
Washout Period (Minimum 72 Hours)
COMPLETED
|
13
|
14
|
|
Washout Period (Minimum 72 Hours)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (Day 4)
STARTED
|
13
|
14
|
|
Period 2 (Day 4)
COMPLETED
|
13
|
14
|
|
Period 2 (Day 4)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
|---|---|---|
|
Washout Period (Minimum 72 Hours)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants
Baseline characteristics by cohort
| Measure |
Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 11.59 • n=7 Participants
|
31.5 Years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol
|
0.622 Hour*nanogram/milliliter (h*ng/mL)
Interval 0.535 to 0.724
|
0.536 Hour*nanogram/milliliter (h*ng/mL)
Interval 0.461 to 0.623
|
PRIMARY outcome
Timeframe: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol
|
21.1 Hour*nanogram/milliliter (h*ng/mL)
Interval 19.7 to 22.6
|
15.0 Hour*nanogram/milliliter (h*ng/mL)
Interval 14.0 to 16.1
|
PRIMARY outcome
Timeframe: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol
|
19.0 Hour*nanogram/millilitre (h*ng/mL)
Interval 17.7 to 20.5
|
13.7 Hour*nanogram/millilitre (h*ng/mL)
Interval 12.7 to 14.7
|
PRIMARY outcome
Timeframe: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Salbutamol
|
2.36 nanogram/millilitre (ng/mL)
Interval 2.15 to 2.6
|
1.80 nanogram/millilitre (ng/mL)
Interval 1.63 to 1.97
|
SECONDARY outcome
Timeframe: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Time to Cmax (Tmax) of Salbutamol
|
2.00 hour (h)
Interval 0.33 to 5.0
|
1.50 hour (h)
Interval 0.05 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Apparent Terminal Phase Half-life (t1/2) of Salbutamol
|
7.650 hour (h)
Geometric Coefficient of Variation 21.1
|
7.297 hour (h)
Geometric Coefficient of Variation 17.1
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic population included all participants who received at least one dose of study intervention and have at least one non-missing potassium concentration result. Only those participants with data available at specified time points have been analyzed.
Minimum observed concentration of potassium levels after dose are presented.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol
|
3.94 millimoles per liter (mmol/L)
Interval 3.884 to 4.003
|
3.96 millimoles per liter (mmol/L)
Interval 3.902 to 4.023
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.
Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)
|
4.15 millimoles per liter (mmol/L)
Interval 4.086 to 4.213
|
4.17 millimoles per liter (mmol/L)
Interval 4.11 to 4.24
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.
Maximum observed heart rate (HR) after dose is presented.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol
|
74.2 Beats per minute (beats/min)
Interval 71.25 to 77.35
|
73.4 Beats per minute (beats/min)
Interval 70.43 to 76.5
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.
Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)
|
61.4 Beats per minute (beats/min)
Interval 58.99 to 63.91
|
60.9 Beats per minute (beats/min)
Interval 58.51 to 63.41
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.
Maximum observed QTcF after dose are presented.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol
|
408.7 Milliseconds
Interval 403.34 to 414.14
|
405.5 Milliseconds
Interval 400.15 to 410.9
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.
Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: \[(C2+C1)/2×(t2-t1)\]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)
|
384.6 Milliseconds
Interval 380.01 to 389.29
|
380.8 Milliseconds
Interval 376.19 to 385.41
|
SECONDARY outcome
Timeframe: Up to 5 daysPopulation: Safety population included all participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=28 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAEs
|
9 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 4 h post-dose
|
152.3 Milliseconds
Standard Deviation 18.51
|
157.7 Milliseconds
Standard Deviation 25.82
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 15 min post-dose
|
398.0 Milliseconds
Standard Deviation 15.00
|
396.3 Milliseconds
Standard Deviation 18.45
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 2 h post-dose
|
393.0 Milliseconds
Standard Deviation 20.55
|
395.5 Milliseconds
Standard Deviation 18.59
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 4 h post-dose
|
397.0 Milliseconds
Standard Deviation 22.25
|
405.4 Milliseconds
Standard Deviation 22.90
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Baseline (Day 1, Predose)
|
402.1 Milliseconds
Standard Deviation 15.47
|
404.2 Milliseconds
Standard Deviation 14.33
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 15 min post-dose
|
396.9 Milliseconds
Standard Deviation 21.86
|
397.1 Milliseconds
Standard Deviation 12.97
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 30 min post-dose
|
399.6 Milliseconds
Standard Deviation 19.47
|
400.1 Milliseconds
Standard Deviation 14.56
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 1 h post-dose
|
400.6 Milliseconds
Standard Deviation 20.43
|
398.9 Milliseconds
Standard Deviation 14.45
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 1.5 h post-dose
|
401.9 Milliseconds
Standard Deviation 18.11
|
399.9 Milliseconds
Standard Deviation 12.09
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 2 h post-dose
|
402.4 Milliseconds
Standard Deviation 16.10
|
396.8 Milliseconds
Standard Deviation 13.55
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 1, 4 h post-dose
|
403.2 Milliseconds
Standard Deviation 19.19
|
403.1 Milliseconds
Standard Deviation 13.57
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Baseline (Day 4, Predose)
|
402.2 Milliseconds
Standard Deviation 14.44
|
397.4 Milliseconds
Standard Deviation 16.30
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 30 min post-dose
|
402.0 Milliseconds
Standard Deviation 14.22
|
398.2 Milliseconds
Standard Deviation 23.29
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 1 h post-dose
|
399.2 Milliseconds
Standard Deviation 17.52
|
398.8 Milliseconds
Standard Deviation 17.62
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 1.5 h post-dose
|
397.9 Milliseconds
Standard Deviation 15.28
|
392.7 Milliseconds
Standard Deviation 19.45
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 2 h post-dose
|
402.9 Milliseconds
Standard Deviation 16.16
|
397.8 Milliseconds
Standard Deviation 17.85
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QTc interval, Day 4, 4 h post-dose
|
402.1 Milliseconds
Standard Deviation 18.19
|
398.2 Milliseconds
Standard Deviation 16.22
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Baseline (Day 1, Predose)
|
160.5 Milliseconds
Standard Deviation 25.47
|
157.1 Milliseconds
Standard Deviation 17.57
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 15 min post-dose
|
149.2 Milliseconds
Standard Deviation 21.93
|
150.2 Milliseconds
Standard Deviation 16.59
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 30 min post-dose
|
149.8 Milliseconds
Standard Deviation 23.13
|
153.2 Milliseconds
Standard Deviation 17.12
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 1 h post-dose
|
151.6 Milliseconds
Standard Deviation 20.25
|
151.4 Milliseconds
Standard Deviation 17.05
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 1.5 h post-dose
|
153.2 Milliseconds
Standard Deviation 22.04
|
154.6 Milliseconds
Standard Deviation 16.99
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 2 h post-dose
|
156.2 Milliseconds
Standard Deviation 23.40
|
153.5 Milliseconds
Standard Deviation 18.47
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 1, 4 h post-dose
|
153.3 Milliseconds
Standard Deviation 24.82
|
154.4 Milliseconds
Standard Deviation 16.40
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Baseline (Day 4, Predose)
|
157.6 Milliseconds
Standard Deviation 18.16
|
159.1 Milliseconds
Standard Deviation 24.95
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 15 min post-dose
|
147.5 Milliseconds
Standard Deviation 17.17
|
146.6 Milliseconds
Standard Deviation 22.61
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 30 min post-dose
|
151.4 Milliseconds
Standard Deviation 17.08
|
151.1 Milliseconds
Standard Deviation 25.81
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 1 h post-dose
|
150.2 Milliseconds
Standard Deviation 15.34
|
153.8 Milliseconds
Standard Deviation 24.73
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 1.5 h post-dose
|
153.6 Milliseconds
Standard Deviation 17.91
|
154.9 Milliseconds
Standard Deviation 21.45
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
PR, Day 4, 2 h post-dose
|
149.3 Milliseconds
Standard Deviation 18.03
|
153.4 Milliseconds
Standard Deviation 22.01
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Baseline (Day 1, Predose)
|
93.0 Milliseconds
Standard Deviation 9.27
|
98.5 Milliseconds
Standard Deviation 9.18
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 15 min post-dose
|
92.0 Milliseconds
Standard Deviation 8.73
|
98.8 Milliseconds
Standard Deviation 10.28
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 30 min post-dose
|
92.1 Milliseconds
Standard Deviation 9.68
|
97.6 Milliseconds
Standard Deviation 11.97
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 1 h post-dose
|
91.5 Milliseconds
Standard Deviation 9.98
|
97.6 Milliseconds
Standard Deviation 10.44
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 1.5 h post-dose
|
92.4 Milliseconds
Standard Deviation 8.87
|
97.0 Milliseconds
Standard Deviation 10.91
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 2 h post-dose
|
92.1 Milliseconds
Standard Deviation 8.12
|
99.4 Milliseconds
Standard Deviation 9.87
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 1, 4 h post-dose
|
91.8 Milliseconds
Standard Deviation 7.95
|
98.0 Milliseconds
Standard Deviation 8.82
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Baseline (Day 4, Predose)
|
97.9 Milliseconds
Standard Deviation 8.99
|
92.4 Milliseconds
Standard Deviation 7.78
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 15 min post-dose
|
96.9 Milliseconds
Standard Deviation 9.56
|
91.4 Milliseconds
Standard Deviation 7.41
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 30 min post-dose
|
97.6 Milliseconds
Standard Deviation 9.58
|
91.6 Milliseconds
Standard Deviation 8.28
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 1 h post-dose
|
96.6 Milliseconds
Standard Deviation 9.04
|
92.2 Milliseconds
Standard Deviation 8.51
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 1.5 h post-dose
|
96.2 Milliseconds
Standard Deviation 11.45
|
92.6 Milliseconds
Standard Deviation 7.02
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 2 h post-dose
|
97.3 Milliseconds
Standard Deviation 8.92
|
93.2 Milliseconds
Standard Deviation 7.96
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QRS duration, Day 4, 4 h post-dose
|
96.3 Milliseconds
Standard Deviation 9.12
|
90.2 Milliseconds
Standard Deviation 8.12
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Baseline (Day 1, Predose)
|
404.2 Milliseconds
Standard Deviation 27.19
|
398.3 Milliseconds
Standard Deviation 19.86
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 15 min post-dose
|
374.9 Milliseconds
Standard Deviation 26.22
|
372.5 Milliseconds
Standard Deviation 18.15
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 30 min post-dose
|
377.2 Milliseconds
Standard Deviation 27.45
|
380.8 Milliseconds
Standard Deviation 21.76
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 1 h post-dose
|
386.7 Milliseconds
Standard Deviation 26.95
|
384.1 Milliseconds
Standard Deviation 23.81
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 1.5 h post-dose
|
393.9 Milliseconds
Standard Deviation 24.80
|
385.3 Milliseconds
Standard Deviation 22.84
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 2 h post-dose
|
399.4 Milliseconds
Standard Deviation 25.22
|
391.2 Milliseconds
Standard Deviation 23.68
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 1, 4 h post-dose
|
407.8 Milliseconds
Standard Deviation 27.67
|
395.7 Milliseconds
Standard Deviation 23.27
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Baseline (Day 4, Predose)
|
400.8 Milliseconds
Standard Deviation 22.66
|
403.5 Milliseconds
Standard Deviation 25.28
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 15 min post-dose
|
373.8 Milliseconds
Standard Deviation 18.52
|
374.2 Milliseconds
Standard Deviation 22.98
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 30 min post-dose
|
379.0 Milliseconds
Standard Deviation 19.41
|
379.8 Milliseconds
Standard Deviation 22.75
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 1 h post-dose
|
382.8 Milliseconds
Standard Deviation 20.18
|
386.2 Milliseconds
Standard Deviation 19.16
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
QT interval, Day 4, 1.5 h post-dose
|
386.7 Milliseconds
Standard Deviation 20.72
|
388.5 Milliseconds
Standard Deviation 20.27
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 1 h post-dose
|
-8.9 Milliseconds
Standard Deviation 13.32
|
-5.6 Milliseconds
Standard Deviation 7.23
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, Baseline (Day 1, Predose)
|
160.5 Milliseconds
Standard Deviation 25.47
|
157.1 Milliseconds
Standard Deviation 17.57
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 15 min post-dose
|
-11.3 Milliseconds
Standard Deviation 11.74
|
-6.9 Milliseconds
Standard Deviation 7.00
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 30 min post-dose
|
-10.7 Milliseconds
Standard Deviation 11.67
|
-3.9 Milliseconds
Standard Deviation 5.14
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 1.5 h post-dose
|
-7.3 Milliseconds
Standard Deviation 9.61
|
-2.5 Milliseconds
Standard Deviation 6.72
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 2 h post-dose
|
-4.3 Milliseconds
Standard Deviation 5.62
|
-3.6 Milliseconds
Standard Deviation 8.06
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 1, 4 h post-dose
|
-7.2 Milliseconds
Standard Deviation 6.57
|
-2.6 Milliseconds
Standard Deviation 5.06
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, Baseline (Day 4, Predose)
|
157.6 Milliseconds
Standard Deviation 18.16
|
159.1 Milliseconds
Standard Deviation 24.95
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 15 min post-dose
|
-10.1 Milliseconds
Standard Deviation 12.11
|
-12.5 Milliseconds
Standard Deviation 9.37
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 30 min post-dose
|
-6.2 Milliseconds
Standard Deviation 8.05
|
-8.0 Milliseconds
Standard Deviation 8.10
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 1 h post-dose
|
-7.4 Milliseconds
Standard Deviation 11.19
|
-5.3 Milliseconds
Standard Deviation 6.46
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 1.5 h post-dose
|
-4.0 Milliseconds
Standard Deviation 9.46
|
-4.2 Milliseconds
Standard Deviation 7.73
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 2 h post-dose
|
-8.4 Milliseconds
Standard Deviation 12.49
|
-5.7 Milliseconds
Standard Deviation 5.59
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
PR, CFB to Day 4, 4 h post-dose
|
-5.4 Milliseconds
Standard Deviation 10.65
|
-1.4 Milliseconds
Standard Deviation 2.50
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, Baseline (Day 1, Predose)
|
93.0 Milliseconds
Standard Deviation 9.27
|
98.5 Milliseconds
Standard Deviation 9.18
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 15 min post-dose
|
-1.0 Milliseconds
Standard Deviation 3.72
|
0.3 Milliseconds
Standard Deviation 4.07
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 30 min post-dose
|
-0.9 Milliseconds
Standard Deviation 4.04
|
-0.9 Milliseconds
Standard Deviation 5.37
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 1 h post-dose
|
-1.5 Milliseconds
Standard Deviation 3.25
|
-0.9 Milliseconds
Standard Deviation 4.37
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 1.5 h post-dose
|
-0.6 Milliseconds
Standard Deviation 3.59
|
-1.5 Milliseconds
Standard Deviation 4.72
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 2 h post-dose
|
-0.9 Milliseconds
Standard Deviation 5.90
|
0.9 Milliseconds
Standard Deviation 5.05
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 1, 4 h post-dose
|
-1.2 Milliseconds
Standard Deviation 4.49
|
-0.5 Milliseconds
Standard Deviation 3.88
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, Baseline (Day 4, Predose)
|
97.9 Milliseconds
Standard Deviation 8.99
|
92.4 Milliseconds
Standard Deviation 7.78
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 15 min post-dose
|
-1.0 Milliseconds
Standard Deviation 5.43
|
-1.0 Milliseconds
Standard Deviation 2.92
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 30 min post-dose
|
-0.2 Milliseconds
Standard Deviation 4.66
|
-0.8 Milliseconds
Standard Deviation 2.42
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 1 h post-dose
|
-1.2 Milliseconds
Standard Deviation 5.54
|
-0.2 Milliseconds
Standard Deviation 3.03
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 1.5 h post-dose
|
-1.6 Milliseconds
Standard Deviation 5.72
|
0.2 Milliseconds
Standard Deviation 3.27
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 2 h post-dose
|
-0.6 Milliseconds
Standard Deviation 5.76
|
0.8 Milliseconds
Standard Deviation 2.52
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QRS duration, CFB to Day 4, 4 h post-dose
|
-1.6 Milliseconds
Standard Deviation 4.45
|
-2.2 Milliseconds
Standard Deviation 4.68
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, Baseline (Day 1, Predose)
|
404.2 Milliseconds
Standard Deviation 27.19
|
398.3 Milliseconds
Standard Deviation 19.86
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 15 min post-dose
|
-29.4 Milliseconds
Standard Deviation 21.45
|
-25.8 Milliseconds
Standard Deviation 9.94
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 30 min post-dose
|
-27.0 Milliseconds
Standard Deviation 20.03
|
-17.5 Milliseconds
Standard Deviation 12.43
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 1 h post-dose
|
-17.5 Milliseconds
Standard Deviation 11.76
|
-14.2 Milliseconds
Standard Deviation 13.22
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 1.5 h post-dose
|
-10.3 Milliseconds
Standard Deviation 13.93
|
-13.0 Milliseconds
Standard Deviation 12.35
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 2 h post-dose
|
-4.9 Milliseconds
Standard Deviation 17.13
|
-7.1 Milliseconds
Standard Deviation 12.43
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 1, 4 h post-dose
|
3.6 Milliseconds
Standard Deviation 14.90
|
-2.6 Milliseconds
Standard Deviation 15.25
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, Baseline (Day 4, Predose)
|
400.8 Milliseconds
Standard Deviation 22.66
|
403.5 Milliseconds
Standard Deviation 25.28
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 15 min post-dose
|
-27.0 Milliseconds
Standard Deviation 11.08
|
-29.2 Milliseconds
Standard Deviation 11.67
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 30 min post-dose
|
-21.8 Milliseconds
Standard Deviation 10.66
|
-23.6 Milliseconds
Standard Deviation 7.61
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 1 h post-dose
|
-18.0 Milliseconds
Standard Deviation 10.77
|
-17.3 Milliseconds
Standard Deviation 12.08
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 1.5 h post-dose
|
-14.1 Milliseconds
Standard Deviation 9.27
|
-15.0 Milliseconds
Standard Deviation 10.79
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 2 h post-dose
|
-7.8 Milliseconds
Standard Deviation 9.43
|
-8.0 Milliseconds
Standard Deviation 12.90
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QT interval, CFB to Day 4, 4 h post-dose
|
-3.8 Milliseconds
Standard Deviation 12.70
|
1.9 Milliseconds
Standard Deviation 11.72
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, Baseline (Day 1, Predose)
|
402.1 Milliseconds
Standard Deviation 15.47
|
404.2 Milliseconds
Standard Deviation 14.33
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 15 min post-dose
|
-5.1 Milliseconds
Standard Deviation 21.16
|
-7.1 Milliseconds
Standard Deviation 6.37
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 30 min post-dose
|
-2.5 Milliseconds
Standard Deviation 17.30
|
-4.1 Milliseconds
Standard Deviation 6.80
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 1 h post-dose
|
-1.4 Milliseconds
Standard Deviation 10.95
|
-5.4 Milliseconds
Standard Deviation 7.11
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 1.5 h post-dose
|
-0.2 Milliseconds
Standard Deviation 7.17
|
-4.4 Milliseconds
Standard Deviation 8.30
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 2 h post-dose
|
0.3 Milliseconds
Standard Deviation 9.79
|
-7.4 Milliseconds
Standard Deviation 7.76
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 1, 4 h post-dose
|
1.1 Milliseconds
Standard Deviation 8.63
|
-1.1 Milliseconds
Standard Deviation 7.68
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, Baseline (Day 4, Predose)
|
402.2 Milliseconds
Standard Deviation 14.44
|
397.4 Milliseconds
Standard Deviation 16.30
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 15 min post-dose
|
-4.2 Milliseconds
Standard Deviation 10.18
|
-1.1 Milliseconds
Standard Deviation 9.09
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 30 min post-dose
|
-0.2 Milliseconds
Standard Deviation 7.51
|
0.8 Milliseconds
Standard Deviation 9.81
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 1 h post-dose
|
-3.0 Milliseconds
Standard Deviation 10.69
|
1.5 Milliseconds
Standard Deviation 6.15
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 1.5 h post-dose
|
-4.3 Milliseconds
Standard Deviation 8.74
|
-4.7 Milliseconds
Standard Deviation 6.24
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 2 h post-dose
|
0.7 Milliseconds
Standard Deviation 9.56
|
0.4 Milliseconds
Standard Deviation 6.21
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
QTc interval, CFB to Day 4, 4 h post-dose
|
-0.1 Milliseconds
Standard Deviation 10.27
|
0.8 Milliseconds
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 4 h post-dose
|
62.7 Beats per minute
Standard Deviation 8.53
|
57.1 Beats per minute
Standard Deviation 7.95
|
|
Absolute Values of ECG Parameter: Heart Rate
Baseline (Day 1, Predose)
|
59.9 Beats per minute
Standard Deviation 10.01
|
63.2 Beats per minute
Standard Deviation 8.12
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 15 min post-dose
|
71.6 Beats per minute
Standard Deviation 8.73
|
73.3 Beats per minute
Standard Deviation 9.51
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 30 min post-dose
|
71.9 Beats per minute
Standard Deviation 9.98
|
70.5 Beats per minute
Standard Deviation 11.80
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 1 h post-dose
|
67.4 Beats per minute
Standard Deviation 8.54
|
67.9 Beats per minute
Standard Deviation 10.86
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 1.5 h post-dose
|
63.9 Beats per minute
Standard Deviation 6.20
|
67.9 Beats per minute
Standard Deviation 9.34
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 2 h post-dose
|
61.5 Beats per minute
Standard Deviation 6.55
|
63.1 Beats per minute
Standard Deviation 8.98
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 1, 4 h post-dose
|
58.4 Beats per minute
Standard Deviation 7.32
|
63.9 Beats per minute
Standard Deviation 9.38
|
|
Absolute Values of ECG Parameter: Heart Rate
Baseline (Day 4, Predose)
|
61.1 Beats per minute
Standard Deviation 8.65
|
57.8 Beats per minute
Standard Deviation 9.53
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 15 min post-dose
|
72.5 Beats per minute
Standard Deviation 7.14
|
71.8 Beats per minute
Standard Deviation 11.16
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 30 min post-dose
|
72.1 Beats per minute
Standard Deviation 10.05
|
69.6 Beats per minute
Standard Deviation 9.89
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 1 h post-dose
|
68.6 Beats per minute
Standard Deviation 9.74
|
66.2 Beats per minute
Standard Deviation 7.80
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 1.5 h post-dose
|
65.9 Beats per minute
Standard Deviation 9.54
|
62.4 Beats per minute
Standard Deviation 8.43
|
|
Absolute Values of ECG Parameter: Heart Rate
Day 4, 2 h post-dose
|
65.0 Beats per minute
Standard Deviation 7.84
|
61.2 Beats per minute
Standard Deviation 7.84
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 15 min post-dose
|
11.4 Beats per minute
Standard Deviation 4.64
|
14.1 Beats per minute
Standard Deviation 7.03
|
|
Change From Baseline in ECG Parameters: Heart Rate
Baseline (Day 1, Predose)
|
59.9 Beats per minute
Standard Deviation 10.01
|
63.2 Beats per minute
Standard Deviation 8.12
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 15 min post-dose
|
11.7 Beats per minute
Standard Deviation 5.61
|
10.1 Beats per minute
Standard Deviation 6.45
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 30 min post-dose
|
12.0 Beats per minute
Standard Deviation 5.35
|
7.3 Beats per minute
Standard Deviation 8.06
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 1 h post-dose
|
7.4 Beats per minute
Standard Deviation 5.37
|
4.7 Beats per minute
Standard Deviation 7.66
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 1.5 h post-dose
|
3.9 Beats per minute
Standard Deviation 6.64
|
4.7 Beats per minute
Standard Deviation 6.67
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 2 h post-dose
|
1.6 Beats per minute
Standard Deviation 7.87
|
-0.1 Beats per minute
Standard Deviation 6.28
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 1, 4 h post-dose
|
-1.6 Beats per minute
Standard Deviation 6.05
|
0.6 Beats per minute
Standard Deviation 7.66
|
|
Change From Baseline in ECG Parameters: Heart Rate
Baseline (Day 4, Predose)
|
61.1 Beats per minute
Standard Deviation 8.65
|
57.8 Beats per minute
Standard Deviation 9.53
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 30 min post-dose
|
11.0 Beats per minute
Standard Deviation 6.63
|
11.8 Beats per minute
Standard Deviation 5.46
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 1 h post-dose
|
7.5 Beats per minute
Standard Deviation 5.63
|
8.5 Beats per minute
Standard Deviation 5.58
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 1.5 h post-dose
|
4.9 Beats per minute
Standard Deviation 4.82
|
4.6 Beats per minute
Standard Deviation 4.46
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 2 h post-dose
|
3.9 Beats per minute
Standard Deviation 4.36
|
3.5 Beats per minute
Standard Deviation 5.80
|
|
Change From Baseline in ECG Parameters: Heart Rate
CFB Day 4, 4 h post-dose
|
1.6 Beats per minute
Standard Deviation 5.89
|
-0.7 Beats per minute
Standard Deviation 5.36
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, Day -1
|
0.03 Giga cells per liter
Standard Deviation 0.047
|
0.02 Giga cells per liter
Standard Deviation 0.037
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, Day 5
|
0.01 Giga cells per liter
Standard Deviation 0.029
|
0.00 Giga cells per liter
Standard Deviation 0.000
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, Day -1
|
0.16 Giga cells per liter
Standard Deviation 0.160
|
0.15 Giga cells per liter
Standard Deviation 0.142
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, Day 5
|
0.15 Giga cells per liter
Standard Deviation 0.094
|
0.18 Giga cells per liter
Standard Deviation 0.124
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, Day -1
|
2.02 Giga cells per liter
Standard Deviation 0.699
|
2.08 Giga cells per liter
Standard Deviation 0.471
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, Day 5
|
1.90 Giga cells per liter
Standard Deviation 0.367
|
1.83 Giga cells per liter
Standard Deviation 0.477
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, Day -1
|
0.43 Giga cells per liter
Standard Deviation 0.133
|
0.42 Giga cells per liter
Standard Deviation 0.107
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, Day 5
|
0.36 Giga cells per liter
Standard Deviation 0.116
|
0.37 Giga cells per liter
Standard Deviation 0.118
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, Day -1
|
4.46 Giga cells per liter
Standard Deviation 1.540
|
4.24 Giga cells per liter
Standard Deviation 1.117
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, Day 5
|
3.20 Giga cells per liter
Standard Deviation 0.954
|
3.15 Giga cells per liter
Standard Deviation 0.996
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet count, Day -1
|
257.07 Giga cells per liter
Standard Deviation 62.390
|
247.64 Giga cells per liter
Standard Deviation 45.865
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet count, Day 5
|
235.50 Giga cells per liter
Standard Deviation 37.293
|
239.85 Giga cells per liter
Standard Deviation 55.306
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
RBC, Day -1
|
4.889 Trillion cells per liter
Standard Deviation 0.3357
|
5.074 Trillion cells per liter
Standard Deviation 0.5315
|
|
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
RBC, Day 5
|
4.703 Trillion cells per liter
Standard Deviation 0.5065
|
4.590 Trillion cells per liter
Standard Deviation 0.2988
|
|
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
Reticulocytes, Day -1
|
0.064 Trillion cells per liter
Standard Deviation 0.0145
|
0.074 Trillion cells per liter
Standard Deviation 0.0179
|
|
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
Reticulocytes, Day 5
|
0.073 Trillion cells per liter
Standard Deviation 0.0159
|
0.065 Trillion cells per liter
Standard Deviation 0.0127
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV).
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Day -1
|
85.07 Femtoliters
Standard Deviation 4.009
|
86.14 Femtoliters
Standard Deviation 4.435
|
|
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 5
|
86.50 Femtoliters
Standard Deviation 4.053
|
85.38 Femtoliters
Standard Deviation 4.273
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH).
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day -1
|
29.453 Picograms
Standard Deviation 1.6398
|
29.832 Picograms
Standard Deviation 1.7107
|
|
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 5
|
30.063 Picograms
Standard Deviation 1.6244
|
29.288 Picograms
Standard Deviation 1.8080
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Hemoglobin.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Hemoglobin
Day -1
|
143.87 Grams per Liter
Standard Deviation 11.978
|
150.79 Grams per Liter
Standard Deviation 11.125
|
|
Absolute Values of Hematology Parameter: Hemoglobin
Day 5
|
140.76 Grams per Liter
Standard Deviation 11.437
|
134.35 Grams per Liter
Standard Deviation 11.602
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Hematocrit.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Hematocrit
Day -1
|
0.416 Percentage
Standard Deviation 0.0352
|
0.436 Percentage
Standard Deviation 0.0313
|
|
Absolute Values of Hematology Parameter: Hematocrit
Day 5
|
0.404 Percentage
Standard Deviation 0.0330
|
0.392 Percentage
Standard Deviation 0.0302
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK).
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALT, Day -1
|
24.21 International units per Liter
Standard Deviation 13.634
|
24.14 International units per Liter
Standard Deviation 11.481
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALT, Day 5
|
26.36 International units per Liter
Standard Deviation 12.959
|
24.38 International units per Liter
Standard Deviation 14.728
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALP, Day -1
|
69.57 International units per Liter
Standard Deviation 20.429
|
66.36 International units per Liter
Standard Deviation 19.262
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALP, Day 5
|
61.93 International units per Liter
Standard Deviation 18.898
|
61.46 International units per Liter
Standard Deviation 20.206
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
AST, Day -1
|
17.64 International units per Liter
Standard Deviation 10.725
|
15.29 International units per Liter
Standard Deviation 4.027
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
AST, Day 5
|
16.29 International units per Liter
Standard Deviation 4.581
|
17.54 International units per Liter
Standard Deviation 11.230
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
CPK, Day -1
|
141.50 International units per Liter
Standard Deviation 106.360
|
121.36 International units per Liter
Standard Deviation 95.447
|
|
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
CPK, Day 5
|
75.71 International units per Liter
Standard Deviation 34.003
|
62.38 International units per Liter
Standard Deviation 20.077
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct Bilirubin, Day -1
|
2.86 Micromoles per liter
Standard Deviation 1.562
|
3.57 Micromoles per liter
Standard Deviation 1.158
|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct Bilirubin, Day 5
|
3.14 Micromoles per liter
Standard Deviation 0.949
|
2.46 Micromoles per liter
Standard Deviation 1.391
|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total Bilirubin, Day -1
|
9.64 Micromoles per liter
Standard Deviation 3.954
|
11.43 Micromoles per liter
Standard Deviation 3.877
|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total Bilirubin, Day 5
|
9.57 Micromoles per liter
Standard Deviation 2.709
|
8.08 Micromoles per liter
Standard Deviation 2.397
|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine, Day -1
|
63.36 Micromoles per liter
Standard Deviation 11.311
|
69.57 Micromoles per liter
Standard Deviation 12.145
|
|
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine, Day 5
|
71.29 Micromoles per liter
Standard Deviation 12.363
|
61.77 Micromoles per liter
Standard Deviation 9.427
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Total protein.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameter: Total Protein
Day -1
|
75.21 Grams per liter
Standard Deviation 3.886
|
73.93 Grams per liter
Standard Deviation 3.149
|
|
Absolute Values of Clinical Chemistry Parameter: Total Protein
Day 5
|
68.57 Grams per liter
Standard Deviation 3.106
|
68.00 Grams per liter
Standard Deviation 2.121
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Calcium, Day -1
|
2.535 Millimoles per liter
Standard Deviation 0.0769
|
2.549 Millimoles per liter
Standard Deviation 0.0934
|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Calcium, Day 5
|
2.466 Millimoles per liter
Standard Deviation 0.0756
|
2.442 Millimoles per liter
Standard Deviation 0.0893
|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Sodium, Day -1
|
140.07 Millimoles per liter
Standard Deviation 0.829
|
139.43 Millimoles per liter
Standard Deviation 1.742
|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Sodium, Day 5
|
140.21 Millimoles per liter
Standard Deviation 1.188
|
139.69 Millimoles per liter
Standard Deviation 1.032
|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
BUN, Day -1
|
4.81 Millimoles per liter
Standard Deviation 0.903
|
4.96 Millimoles per liter
Standard Deviation 1.709
|
|
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
BUN, Day 5
|
4.66 Millimoles per liter
Standard Deviation 1.203
|
4.38 Millimoles per liter
Standard Deviation 0.791
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analyzing absolute values of glucose.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 4 h post-dose
|
4.74 Millimoles per liter
Standard Deviation 0.378
|
4.71 Millimoles per liter
Standard Deviation 0.348
|
|
Absolute Values for Chemistry Parameter: Glucose
Baseline (Day 4, Predose)
|
4.76 Millimoles per liter
Standard Deviation 0.290
|
5.03 Millimoles per liter
Standard Deviation 0.964
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 15 min post-dose
|
5.06 Millimoles per liter
Standard Deviation 0.838
|
5.24 Millimoles per liter
Standard Deviation 2.514
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 30 min post-dose
|
5.13 Millimoles per liter
Standard Deviation 0.637
|
5.34 Millimoles per liter
Standard Deviation 2.064
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 1 h post-dose
|
5.15 Millimoles per liter
Standard Deviation 0.455
|
5.33 Millimoles per liter
Standard Deviation 1.434
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 1.5 h post-dose
|
5.11 Millimoles per liter
Standard Deviation 0.296
|
5.24 Millimoles per liter
Standard Deviation 1.171
|
|
Absolute Values for Chemistry Parameter: Glucose
Baseline (Day 1, Predose)
|
5.04 Millimoles per liter
Standard Deviation 0.599
|
4.89 Millimoles per liter
Standard Deviation 0.297
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 15 min post-dose
|
5.43 Millimoles per liter
Standard Deviation 2.067
|
5.02 Millimoles per liter
Standard Deviation 0.587
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 30 min post-dose
|
5.64 Millimoles per liter
Standard Deviation 1.790
|
5.14 Millimoles per liter
Standard Deviation 0.482
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 1 h post-dose
|
5.47 Millimoles per liter
Standard Deviation 1.221
|
5.24 Millimoles per liter
Standard Deviation 0.533
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 1.5 h post-dose
|
5.44 Millimoles per liter
Standard Deviation 0.925
|
5.11 Millimoles per liter
Standard Deviation 0.369
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 1, 2 h post-dose
|
5.24 Millimoles per liter
Standard Deviation 0.626
|
4.90 Millimoles per liter
Standard Deviation 0.335
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 2 h post-dose
|
4.96 Millimoles per liter
Standard Deviation 0.262
|
5.11 Millimoles per liter
Standard Deviation 0.999
|
|
Absolute Values for Chemistry Parameter: Glucose
Day 4, 4 h post-dose
|
4.71 Millimoles per liter
Standard Deviation 0.248
|
4.66 Millimoles per liter
Standard Deviation 0.380
|
SECONDARY outcome
Timeframe: On Day -1 (admission) and Day 5 (Discharge)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day -1 · (+)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day -1 · +
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day -1 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day -1 · Negative
|
14 Participants
|
13 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day 5 · (+)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day 5 · +
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day 5 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Protein, Day 5 · Negative
|
14 Participants
|
12 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day -1 · (+)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day -1 · +
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day -1 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day -1 · Negative
|
14 Participants
|
14 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day 5 · (+)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day 5 · +
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day 5 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Glucose, Day 5 · Negative
|
14 Participants
|
13 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day -1 · (+)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day -1 · +
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day -1 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day -1 · Negative
|
14 Participants
|
14 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day 5 · (+)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day 5 · +
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day 5 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Ketones, Day 5 · Negative
|
13 Participants
|
12 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day -1 · (+)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day -1 · +
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day -1 · ++
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day -1 · Negative
|
12 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day 5 · (+)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day 5 · +
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day 5 · ++
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine Hemoglobin, Day 5 · Negative
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood pressure measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 1 h post-dose
|
67.8 Millimeters of mercury [mmHg]
Standard Deviation 7.16
|
67.4 Millimeters of mercury [mmHg]
Standard Deviation 8.78
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 1.5 h post-dose
|
65.3 Millimeters of mercury [mmHg]
Standard Deviation 5.98
|
67.8 Millimeters of mercury [mmHg]
Standard Deviation 8.46
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Baseline (Day 1, Predose)
|
69.1 Millimeters of mercury [mmHg]
Standard Deviation 6.27
|
69.4 Millimeters of mercury [mmHg]
Standard Deviation 7.21
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 15 min post-dose
|
68.2 Millimeters of mercury [mmHg]
Standard Deviation 6.42
|
67.8 Millimeters of mercury [mmHg]
Standard Deviation 7.82
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 30 min post-dose
|
70.6 Millimeters of mercury [mmHg]
Standard Deviation 9.30
|
69.1 Millimeters of mercury [mmHg]
Standard Deviation 9.21
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 2 h post-dose
|
66.3 Millimeters of mercury [mmHg]
Standard Deviation 4.18
|
66.1 Millimeters of mercury [mmHg]
Standard Deviation 8.23
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, 4 h post-dose
|
68.1 Millimeters of mercury [mmHg]
Standard Deviation 6.44
|
67.6 Millimeters of mercury [mmHg]
Standard Deviation 8.99
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Baseline (Day 4, Predose)
|
72.1 Millimeters of mercury [mmHg]
Standard Deviation 6.64
|
67.9 Millimeters of mercury [mmHg]
Standard Deviation 5.51
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 15 min post-dose
|
67.4 Millimeters of mercury [mmHg]
Standard Deviation 7.59
|
64.9 Millimeters of mercury [mmHg]
Standard Deviation 4.33
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 30 min post-dose
|
67.0 Millimeters of mercury [mmHg]
Standard Deviation 6.23
|
63.8 Millimeters of mercury [mmHg]
Standard Deviation 4.44
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 1 h post-dose
|
68.5 Millimeters of mercury [mmHg]
Standard Deviation 7.86
|
65.4 Millimeters of mercury [mmHg]
Standard Deviation 3.69
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 1.5 h post-dose
|
67.4 Millimeters of mercury [mmHg]
Standard Deviation 6.48
|
63.6 Millimeters of mercury [mmHg]
Standard Deviation 5.17
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 2 h post-dose
|
67.9 Millimeters of mercury [mmHg]
Standard Deviation 7.71
|
64.1 Millimeters of mercury [mmHg]
Standard Deviation 5.78
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 4, 4 h post-dose
|
68.5 Millimeters of mercury [mmHg]
Standard Deviation 6.31
|
65.6 Millimeters of mercury [mmHg]
Standard Deviation 6.13
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Baseline (Day 1, Predose)
|
111.9 Millimeters of mercury [mmHg]
Standard Deviation 8.49
|
113.0 Millimeters of mercury [mmHg]
Standard Deviation 10.24
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 15 min post-dose
|
118.2 Millimeters of mercury [mmHg]
Standard Deviation 9.00
|
119.1 Millimeters of mercury [mmHg]
Standard Deviation 10.27
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 30 min post-dose
|
121.6 Millimeters of mercury [mmHg]
Standard Deviation 15.05
|
118.6 Millimeters of mercury [mmHg]
Standard Deviation 10.48
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 1 h post-dose
|
114.9 Millimeters of mercury [mmHg]
Standard Deviation 9.14
|
116.7 Millimeters of mercury [mmHg]
Standard Deviation 8.91
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 1.5 h post-dose
|
110.1 Millimeters of mercury [mmHg]
Standard Deviation 8.27
|
115.7 Millimeters of mercury [mmHg]
Standard Deviation 10.36
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 2 h post-dose
|
111.5 Millimeters of mercury [mmHg]
Standard Deviation 8.54
|
112.9 Millimeters of mercury [mmHg]
Standard Deviation 10.57
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, 4 h post-dose
|
112.5 Millimeters of mercury [mmHg]
Standard Deviation 8.84
|
112.0 Millimeters of mercury [mmHg]
Standard Deviation 10.91
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Baseline (Day 4, Predose)
|
114.8 Millimeters of mercury [mmHg]
Standard Deviation 8.31
|
108.6 Millimeters of mercury [mmHg]
Standard Deviation 7.15
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 15 min post-dose
|
119.1 Millimeters of mercury [mmHg]
Standard Deviation 9.68
|
116.1 Millimeters of mercury [mmHg]
Standard Deviation 9.72
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 30 min post-dose
|
119.8 Millimeters of mercury [mmHg]
Standard Deviation 10.96
|
112.5 Millimeters of mercury [mmHg]
Standard Deviation 7.87
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 1 h post-dose
|
115.2 Millimeters of mercury [mmHg]
Standard Deviation 8.74
|
111.6 Millimeters of mercury [mmHg]
Standard Deviation 11.15
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 1.5 h post-dose
|
115.9 Millimeters of mercury [mmHg]
Standard Deviation 12.07
|
109.2 Millimeters of mercury [mmHg]
Standard Deviation 7.61
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 2 h post-dose
|
115.9 Millimeters of mercury [mmHg]
Standard Deviation 11.84
|
108.2 Millimeters of mercury [mmHg]
Standard Deviation 10.60
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 4, 4 h post-dose
|
113.6 Millimeters of mercury [mmHg]
Standard Deviation 11.04
|
108.9 Millimeters of mercury [mmHg]
Standard Deviation 9.18
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Salbutamol HFA-152a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=14 Participants
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Absolute Values of Pulse Rate
Day 4, 1.5 h post-dose
|
66.1 Beats per minute
Standard Deviation 9.62
|
62.3 Beats per minute
Standard Deviation 7.66
|
|
Absolute Values of Pulse Rate
Baseline (Day 1, Predose)
|
58.6 Beats per minute
Standard Deviation 9.43
|
61.7 Beats per minute
Standard Deviation 9.75
|
|
Absolute Values of Pulse Rate
Day 1, 15 min post-dose
|
70.8 Beats per minute
Standard Deviation 9.54
|
71.8 Beats per minute
Standard Deviation 11.43
|
|
Absolute Values of Pulse Rate
Day 1, 30 min post-dose
|
69.4 Beats per minute
Standard Deviation 9.04
|
73.5 Beats per minute
Standard Deviation 12.86
|
|
Absolute Values of Pulse Rate
Day 1, 1 h post-dose
|
65.9 Beats per minute
Standard Deviation 9.14
|
68.9 Beats per minute
Standard Deviation 12.89
|
|
Absolute Values of Pulse Rate
Day 1, 1.5 h post-dose
|
63.6 Beats per minute
Standard Deviation 8.32
|
67.1 Beats per minute
Standard Deviation 11.01
|
|
Absolute Values of Pulse Rate
Day 1, 2 h post-dose
|
60.1 Beats per minute
Standard Deviation 7.79
|
65.1 Beats per minute
Standard Deviation 11.46
|
|
Absolute Values of Pulse Rate
Day 1, 4 h post-dose
|
58.3 Beats per minute
Standard Deviation 8.07
|
64.6 Beats per minute
Standard Deviation 10.27
|
|
Absolute Values of Pulse Rate
Baseline (Day 4, Predose)
|
60.8 Beats per minute
Standard Deviation 9.77
|
55.2 Beats per minute
Standard Deviation 8.23
|
|
Absolute Values of Pulse Rate
Day 4, 15 min post-dose
|
74.1 Beats per minute
Standard Deviation 10.81
|
69.9 Beats per minute
Standard Deviation 8.41
|
|
Absolute Values of Pulse Rate
Day 4, 30 min post-dose
|
71.2 Beats per minute
Standard Deviation 9.89
|
66.3 Beats per minute
Standard Deviation 8.26
|
|
Absolute Values of Pulse Rate
Day 4, 1 h post-dose
|
69.3 Beats per minute
Standard Deviation 10.09
|
64.2 Beats per minute
Standard Deviation 8.21
|
|
Absolute Values of Pulse Rate
Day 4, 2 h post-dose
|
65.1 Beats per minute
Standard Deviation 9.29
|
60.5 Beats per minute
Standard Deviation 7.88
|
|
Absolute Values of Pulse Rate
Day 4, 4 h post-dose
|
62.9 Beats per minute
Standard Deviation 9.11
|
58.2 Beats per minute
Standard Deviation 6.84
|
Adverse Events
Salbutamol HFA-152a MDI
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Salbutamol HFA-134a MDI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Salbutamol HFA-152a MDI
n=28 participants at risk
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
Salbutamol HFA-134a MDI
n=27 participants at risk
Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
14.8%
4/27 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/28 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
7.4%
2/27 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
|
General disorders
Vessel puncture site bruise
|
7.1%
2/28 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/27 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
7.4%
2/27 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER