Trial Outcomes & Findings for Zaleplon 10 mg Capsules Under Non-Fasting Conditions (NCT NCT00829868)

NCT ID: NCT00829868

Last Updated: 2024-08-21

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 42 participants
• Primary outcome timeframe: Blood samples collected over 12 hour period
• Results posted on: 2024-08-21

Participant Flow

Participant milestones

Measure	Zaleplon (Test) First Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period	Sonata® (Reference) First Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
First Intervention STARTED	21	21
First Intervention COMPLETED	21	21
First Intervention NOT COMPLETED	0	0
Washout STARTED	21	21
Washout COMPLETED	20	21
Washout NOT COMPLETED	1	0
Second Intervention STARTED	20	21
Second Intervention COMPLETED	20	21
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Zaleplon (Test) First Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period	Sonata® (Reference) First Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
Washout Physician Decision	1	0

Baseline Characteristics

Zaleplon 10 mg Capsules Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Zaleplon (Test) First n=21 Participants Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period	Sonata® (Reference) First n=21 Participants Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period	Total n=42 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	21 Participants n=5 Participants	21 Participants n=7 Participants	42 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	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Biracial	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 12 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Zaleplon n=41 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=41 Participants Sonata® 10 mg Capsule (reference) dosed in either period
Cmax - Maximum Observed Concentration	18.125 ng/mL Standard Deviation 8.267	16.258 ng/mL Standard Deviation 6.212

PRIMARY outcome

Timeframe: Blood samples collected over 12 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	Zaleplon n=41 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=41 Participants Sonata® 10 mg Capsule (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	64.760 ng*h/mL Standard Deviation 22.564	64.926 ng*h/mL Standard Deviation 21.929

PRIMARY outcome

Timeframe: Blood samples collected over 12 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	Zaleplon n=41 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=41 Participants Sonata® 10 mg Capsule (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)	63.466 ng*h/mL Standard Deviation 21.804	62.878 ng*h/mL Standard Deviation 20.938

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