Trial Outcomes & Findings for Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions (NCT NCT00829426)

NCT ID: NCT00829426

Last Updated: 2024-09-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Alprazolam (Test) First Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period	Xanax® (Reference) First Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
First Intervention STARTED	16	16
First Intervention COMPLETED	16	16
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	16	16
Washout: 7 Days COMPLETED	15	16
Washout: 7 Days NOT COMPLETED	1	0
Second Intervention STARTED	15	16
Second Intervention COMPLETED	15	16
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

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

Baseline Characteristics

Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions

Baseline characteristics by cohort

Measure	Alprazolam (Test) First n=16 Participants Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period	Xanax® (Reference) First n=16 Participants Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period	Total n=32 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	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	12 Participants n=7 Participants	27 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American or Alaskan Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 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=31 Participants Alprazolam 3 mg ER Tablet (test) dosed in either period	Xanax® n=31 Participants Xanax XR® 3 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	24.33 ng/mL Standard Deviation 5.37	23.62 ng/mL Standard Deviation 4.29

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=31 Participants Alprazolam 3 mg ER Tablet (test) dosed in either period	Xanax® n=31 Participants Xanax XR® 3 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	668.79 ng*h/mL Standard Deviation 250.55	725.34 ng*h/mL Standard Deviation 291.34

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=31 Participants Alprazolam 3 mg ER Tablet (test) dosed in either period	Xanax® n=31 Participants Xanax XR® 3 mg Tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	620.40 ng*h/mL Standard Deviation 213.87	663.08 ng*h/mL Standard Deviation 226.97

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, 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