Trial Outcomes & Findings for Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions (NCT NCT00830024)

NCT ID: NCT00830024

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Test First Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period	Reference First Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
First Intervention STARTED	18	18
First Intervention COMPLETED	18	18
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	18	18
Washout: 7 Days COMPLETED	17	18
Washout: 7 Days NOT COMPLETED	1	0
Second Intervention STARTED	17	18
Second Intervention COMPLETED	17	18
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Test First Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period	Reference First Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
Washout: 7 Days Withdrawal by Subject	1	0

Baseline Characteristics

Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions

Baseline characteristics by cohort

Measure	Test First n=18 Participants Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period	Reference First n=18 Participants Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Alprazolam n=35 Participants Alprazolam Extended Release Tablet 3 mg test product dosed in either period	Xanax XR® n=35 Participants Xanax XR® Tablet 3 mg reference product dosed in either period
Cmax - Maximum Observed Concentration	28.79 ng/mL Standard Deviation 6.35	28.95 ng/mL Standard Deviation 5.38

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Alprazolam n=35 Participants Alprazolam Extended Release Tablet 3 mg test product dosed in either period	Xanax XR® n=35 Participants Xanax XR® Tablet 3 mg reference product dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	650.91 ng*h/mL Standard Deviation 249.36	683.25 ng*h/mL Standard Deviation 289.69

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Alprazolam n=35 Participants Alprazolam Extended Release Tablet 3 mg test product dosed in either period	Xanax XR® n=35 Participants Xanax XR® Tablet 3 mg reference product dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	600.24 ng*h/mL Standard Deviation 199.80	626.54 ng*h/mL Standard Deviation 216.46

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manger, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER