Healthy
Conditions
Keywords
Bioequivalence, Healthy Subjects
Brief summary
The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Interventions
1 x 40 mg
1 x 40 mg
Sponsors
Teva Pharmaceuticals USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI(Body Mass Index) of 30 or less.
Exclusion criteria
* Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular, disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study. * Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant. * Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study. * All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate. * Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study will not be allowed to participate. * Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate. * All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study. * Subjects who do no tolerate venipuncture will not be allowed to participate. * Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax - Maximum Observed Concentration - Pantoprazole in Plasma | Blood samples collected over 16 hour period | Bioequivalence based on Cmax |
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Blood samples collected over 16 hour period | Bioequivalence based on AUC0-inf |
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Blood samples collected over 16 hour period | Bioequivalence based on AUC0-t |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Pantoprazole (Test) First | Protonix® (Reference) First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Race/Ethnicity, Customized American Indian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 41 Participants | 42 Participants | 83 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 31 Participants | 36 Participants | 67 Participants |
Outcome results
Primary
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUC0-inf
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | 6280.022 ng*h/mL | Standard Deviation 6311.033 |
| Protonix® | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | 6332.279 ng*h/mL | Standard Deviation 5923.458 |
90% CI: [93.4, 101]
Primary
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 16 hour period
Population: Data from all subjects who completed the study were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | 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 |
| Protonix® | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | 6016.176 ng*h/mL | Standard Deviation 4502.333 |
90% CI: [91.6, 99.8]
Primary
Cmax - Maximum Observed Concentration - Pantoprazole in Plasma
Bioequivalence based on Cmax
Time frame: Blood samples collected over 16 hour period
Population: Data from all subjects who completed the study were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | Cmax - Maximum Observed Concentration - Pantoprazole in Plasma | 2494.120 ng/mL | Standard Deviation 965.022 |
| Protonix® | Cmax - Maximum Observed Concentration - Pantoprazole in Plasma | 2747.380 ng/mL | Standard Deviation 879.942 |
90% CI: [82.7, 95.4]