Trial Outcomes & Findings for Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions (NCT NCT00829309)

NCT ID: NCT00829309

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Blood samples collected over 16 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
First Intervention STARTED	8	8
First Intervention COMPLETED	8	8
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	8	8
Washout: 7 Days COMPLETED	7	8
Washout: 7 Days NOT COMPLETED	1	0
Second Intervention STARTED	7	8
Second Intervention COMPLETED	7	8
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
Washout: 7 Days Protocol Violation	1	0

Baseline Characteristics

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Pravastatin (Test) First n=8 Participants Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First n=8 Participants Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period	Total n=16 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	8 Participants n=5 Participants	8 Participants n=7 Participants	16 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 16 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Pravastatin n=15 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=15 Participants Pravachol® 80 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Pravastatin in Plasma	126.69 ng/mL Standard Deviation 60.95	130.64 ng/mL Standard Deviation 58.86

PRIMARY outcome

Timeframe: Blood samples collected over 16 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Data from one subject could not be included in the AUC0-inf calculation for Pravachol®.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Pravastatin n=15 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=14 Participants Pravachol® 80 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	273.32 ng*h/mL Standard Deviation 116.86	299.56 ng*h/mL Standard Deviation 121.83

PRIMARY outcome

Timeframe: Blood samples collected over 16 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	Pravastatin n=15 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=15 Participants Pravachol® 80 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)	241.29 ng*h/mL Standard Deviation 104.11	251.86 ng*h/mL Standard Deviation 111.26

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