Trial Outcomes & Findings for Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions (NCT NCT05300087)
NCT ID: NCT05300087
Last Updated: 2024-03-18
Results Overview
The maximal observed plasma concentration of Albuterol Sulfate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Results posted on
2024-03-18
Participant Flow
Ninety-seven subjects were recruited and screened for the eligibility.
Sixty eligible subjects were randomized in the study.
Participant milestones
| Measure |
Albuterol Sulfate Inhalation Aerosol First, Then ProairHFA (Albuterol Sulfate) Inhalation Aerosol
Subjects who were randomized to the sequence of Albuterol Sulfate Inhalation Aerosol first, then ProairHFA (albuterol sulfate) Inhalation Aerosol received an orally inhaled dose of 2 puffs of the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) in First Intervention Period 1. After a Washout (14 days) period, subjects received an orally inhaled dose of 2 puffs of the reference product (Proair HFA \[albuterol sulfate\] Inhalation Aerosol 90 mcg per actuation) in the Second Intervention Period 2.
|
Proair HFA (Albuterol Sulfate) InhalationAerosol First, Then Albuterol Sulfate Inhalation Aerosol
Subjects who were randomized to the sequence of Proair HFA (albuterol sulfate) Inhalation Aerosol first, then Albuterol Sulfate Inhalation Aerosol received an orally inhaled dose of 2 puffs of the reference product (Proair HFA \[albuterol sulfate\] Inhalation Aerosol 90 mcg per actuation) in First Intervention Period 1. After a Washout (14 days) period, subjects received an orally inhaled dose of 2 puffs of the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) in the Second Intervention Period 2.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Albuterol Sulfate Inhalation Aerosol First, Then ProairHFA (Albuterol Sulfate) Inhalation Aerosol
Subjects who were randomized to the sequence of Albuterol Sulfate Inhalation Aerosol first, then ProairHFA (albuterol sulfate) Inhalation Aerosol received an orally inhaled dose of 2 puffs of the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) in First Intervention Period 1. After a Washout (14 days) period, subjects received an orally inhaled dose of 2 puffs of the reference product (Proair HFA \[albuterol sulfate\] Inhalation Aerosol 90 mcg per actuation) in the Second Intervention Period 2.
|
Proair HFA (Albuterol Sulfate) InhalationAerosol First, Then Albuterol Sulfate Inhalation Aerosol
Subjects who were randomized to the sequence of Proair HFA (albuterol sulfate) Inhalation Aerosol first, then Albuterol Sulfate Inhalation Aerosol received an orally inhaled dose of 2 puffs of the reference product (Proair HFA \[albuterol sulfate\] Inhalation Aerosol 90 mcg per actuation) in First Intervention Period 1. After a Washout (14 days) period, subjects received an orally inhaled dose of 2 puffs of the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) in the Second Intervention Period 2.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
All Study Participants
n=59 Participants
Summary of Demographic Data and Baseline Characteristics for All Study Participants
|
|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Height
|
169.6 cm
STANDARD_DEVIATION 7.5 • n=93 Participants
|
|
Weight
|
67.3 kg
STANDARD_DEVIATION 9.0 • n=93 Participants
|
|
Body mass index (BMI)
|
23.4 kg/m^2
STANDARD_DEVIATION 2.2 • n=93 Participants
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-doseThe maximal observed plasma concentration of Albuterol Sulfate.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Cmax
|
996.998 pg/mL
Standard Deviation 333.469
|
979.630 pg/mL
Standard Deviation 315.945
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-doseArea under the concentration time curve from time zero until the last measurable concentration or last sampling time t, whichever occurs first.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
AUC(0-t)
|
5738.664 hr*pg/mL
Standard Deviation 1092.069
|
5620.377 hr*pg/mL
Standard Deviation 1095.309
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-doseArea under the concentration time curve from time zero to infinity.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
AUC(0-inf)
|
6236.317 hr*pg/mL
Standard Deviation 1240.626
|
6111.557 hr*pg/mL
Standard Deviation 1229.386
|
SECONDARY outcome
Timeframe: 0-24 hoursTime when the maximal plasma concentration is observed.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Tmax
|
0.643 hr
Standard Deviation 0.733
|
0.704 hr
Standard Deviation 0.974
|
SECONDARY outcome
Timeframe: 0-24 hoursTerminal elimination half-life, estimated as ln(2)/λ.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
T1/2
|
7.049 hr
Standard Deviation 1.431
|
7.043 hr
Standard Deviation 1.561
|
SECONDARY outcome
Timeframe: 0-24 hoursTerminal elimination rate constant, estimated by linear regression analysis of the terminal portion of the ln-concentration vs. time plot.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Kel(λ)
|
0.102 1/hr
Standard Deviation 0.020
|
0.103 1/hr
Standard Deviation 0.021
|
SECONDARY outcome
Timeframe: 0-24 hoursMean residence time (MRT) is calculated by the area under the first moment curve dividing by area under the concentration time curve
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=59 Participants
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=59 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Mean Residence Time (MRT)
|
8.731 hr
Standard Deviation 1.450
|
8.753 hr
Standard Deviation 1.637
|
Adverse Events
Test Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Reference Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Group
n=59 participants at risk
Albuterol Sulfate Inhalation Aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Reference Group
n=59 participants at risk
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
1.7%
1/59 • Approximately 16 days for each subject.
The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place