Trial Outcomes & Findings for Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions (NCT NCT00835588)

NCT ID: NCT00835588

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 100 participants
• Primary outcome timeframe: Blood samples collected over 16 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Pantoprazole (Test) First Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period	Protonix® (Reference) First Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
First Intervention STARTED	50	50
First Intervention COMPLETED	50	50
First Intervention NOT COMPLETED	0	0
Washout: 5 Days STARTED	50	50
Washout: 5 Days COMPLETED	50	50
Washout: 5 Days NOT COMPLETED	0	0
Second Intervention STARTED	50	50
Second Intervention COMPLETED	50	50
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Pantoprazole (Test) First n=50 Participants Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period	Protonix® (Reference) First n=50 Participants Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	36 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants	42 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized Black	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 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	Pantoprazole n=100 Participants Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period	Protonix® n=100 Participants Protonix 40 mg DR Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Pantoprazole in Plasma	2494.120 ng/mL Standard Deviation 965.022	2747.380 ng/mL Standard Deviation 879.942

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. Not all subjects data could be used to estimate AUC0-inf.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Pantoprazole n=96 Participants Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period	Protonix® n=99 Participants Protonix 40 mg DR Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	6280.022 ng*h/mL Standard Deviation 6311.033	6332.279 ng*h/mL Standard Deviation 5923.458

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	Pantoprazole n=100 Participants Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period	Protonix® n=100 Participants Protonix 40 mg DR 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)	5822.470 ng*h/mL Standard Deviation 4825.928	6016.176 ng*h/mL Standard Deviation 4502.333

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