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
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 16 hour periodPopulation: 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 periodPopulation: 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 periodPopulation: 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
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