Trial Outcomes & Findings for Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions (NCT NCT04803734)
NCT ID: NCT04803734
Last Updated: 2024-03-18
Results Overview
The maximal observed plasma concentration of Albuterol Sulfate.
COMPLETED
NA
60 participants
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
2024-03-18
Participant Flow
Eighty-four 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 the 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) Inhalation Aerosol 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 the 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.
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|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
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 the 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) Inhalation Aerosol 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 the 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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
All Study Participants
n=60 Participants
Summary of Demographic Data and Baseline Characteristics for All Study Participants.
|
|---|---|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
167.8 cm
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Weight
|
65.5 kg
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Body mass index (BMI)
|
23.2 kg/m^2
STANDARD_DEVIATION 2.2 • n=5 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-dosePopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
The maximal observed plasma concentration of Albuterol Sulfate.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Cmax
|
812.477 pg/mL
Standard Deviation 281.148
|
945.456 pg/mL
Standard Deviation 359.695
|
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-dosePopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Area 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=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
AUC(0-t)
|
4806.319 hr*pg/mL
Standard Deviation 981.477
|
5090.449 hr*pg/mL
Standard Deviation 1053.602
|
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-dosePopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Area under the concentration time curve from time zero to infinity.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
AUC(0-inf)
|
5204.806 hr*pg/mL
Standard Deviation 1081.862
|
5509.006 hr*pg/mL
Standard Deviation 1148.747
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SECONDARY outcome
Timeframe: 0-24 hoursPopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Time when the maximal plasma concentration is observed.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Tmax
|
0.929 hr
Standard Deviation 1.089
|
0.514 hr
Standard Deviation 0.529
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Terminal elimination half-life, estimated as ln(2)/λ.
Outcome measures
| Measure |
Albuterol Sulfate Inhalation Aerosol
n=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
T1/2
|
6.928 hr
Standard Deviation 1.165
|
6.985 hr
Standard Deviation 1.357
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Terminal 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=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Kel(λ)
|
0.103 1/hr
Standard Deviation 0.019
|
0.103 1/hr
Standard Deviation 0.021
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: R014, R040, R055, R058 had protocol issues including significantly delayed blood sampling and leakage of drug during dosing. R029 and R058 had pre-dose concentrations \> 5% of Cmax. Data of remaining 53 subjects was considered for pharmacokinetic and statistical analysis.
Mean 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=53 Participants
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Proair HFA (Albuterol Sulfate) Inhalation Aerosol
n=53 Participants
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Mean Residence Time (MRT)
|
8.629 hr
Standard Deviation 1.202
|
8.474 hr
Standard Deviation 1.455
|
Adverse Events
Test Group
Reference Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Group
n=60 participants at risk
Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
Reference Group
n=58 participants at risk
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting
|
|---|---|---|
|
Infections and infestations
Throat infection
|
1.7%
1/60 • 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%
0/58 • 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
Aspartate aminotransferase (AST) increased
|
1.7%
1/60 • 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%
0/58 • 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
Creatinine increased
|
1.7%
1/60 • 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%
0/58 • 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
Alanine aminotransferase (ALT) increased
|
1.7%
1/60 • 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%
0/58 • 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
Hypertriglyceridemia
|
0.00%
0/60 • 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%
1/58 • 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