Trial Outcomes & Findings for Zaleplon 10mg Capsules Under Fasting Conditions (NCT NCT00829998)

NCT ID: NCT00829998

Last Updated: 2024-08-21

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: Blood samples collected over 10 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	20
First Intervention COMPLETED	21	20
First Intervention NOT COMPLETED	0	0
Washout STARTED	21	20
Washout COMPLETED	21	19
Washout NOT COMPLETED	0	1
Second Intervention STARTED	21	19
Second Intervention COMPLETED	21	19
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 Adverse Event	0	1

Baseline Characteristics

Zaleplon 10mg Capsules Under 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=20 Participants Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period	Total n=41 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	20 Participants n=7 Participants	41 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	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Black	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 10 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=40 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=40 Participants Sonata® 10 mg Capsule (reference) dosed in either period
Cmax - Maximum Observed Concentration	27.080 ng/mL Standard Deviation 12.369	27.487 ng/mL Standard Deviation 12.763

PRIMARY outcome

Timeframe: Blood samples collected over 10 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=40 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=40 Participants Sonata® 10 mg Capsule (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	54.288 ng*h/mL Standard Deviation 20.933	53.525 ng*h/mL Standard Deviation 23.143

PRIMARY outcome

Timeframe: Blood samples collected over 10 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=40 Participants Zaleplon 10 mg Capsule (test) dosed in either period	Sonata® n=40 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)	53.766 ng*h/mL Standard Deviation 20.861	52.966 ng*h/mL Standard Deviation 23.069

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