Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pantoprazole Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period |
Drug: Pantoprazole Sodium 40 mg delayed-release tablets
1 x 40 mg
|
Active Comparator: Protonix® Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period |
Drug: PROTONIX® 40 mg delayed-release tablets.
1 x 40 mg
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Gateway Medical Research, Inc. | St. Charles | Missouri | United States | 63301 |
2 | Bioassay Laboratory, Inc. | Houston | Texas | United States | 77099 |
Sponsors and Collaborators
- Teva Pharmaceuticals USA
Investigators
- Principal Investigator: Steven Herrmann, M.D.; Ph.D, Cetero Research, San Antonio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B036581
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Pantoprazole (Test) First | Protonix® (Reference) First |
---|---|---|
Arm/Group Description | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period | Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period |
Period Title: First Intervention | ||
STARTED | 50 | 50 |
COMPLETED | 50 | 50 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention | ||
STARTED | 50 | 50 |
COMPLETED | 50 | 50 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention | ||
STARTED | 50 | 50 |
COMPLETED | 50 | 50 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Pantoprazole (Test) First | Protonix® (Reference) First | Total |
---|---|---|---|
Arm/Group Description | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period | Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period | Total of all reporting groups |
Overall Participants | 50 | 50 | 100 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
50
100%
|
50
100%
|
100
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
19
38%
|
14
28%
|
33
33%
|
Male |
31
62%
|
36
72%
|
67
67%
|
Race/Ethnicity, Customized (Number) [Number] | |||
Caucasian |
41
82%
|
42
84%
|
83
83%
|
Black |
5
10%
|
5
10%
|
10
10%
|
American Indian |
1
2%
|
1
2%
|
2
2%
|
Asian |
1
2%
|
0
0%
|
1
1%
|
Hispanic |
2
4%
|
1
2%
|
3
3%
|
Other |
0
0%
|
1
2%
|
1
1%
|
Region of Enrollment (participants) [Number] | |||
United States |
50
100%
|
50
100%
|
100
100%
|
Outcome Measures
Title | Cmax - Maximum Observed Concentration - Pantoprazole in Plasma |
---|---|
Description | Bioequivalence based on Cmax |
Time Frame | Blood samples collected over 16 hour period |
Outcome Measure Data
Analysis Population Description |
---|
Data from all subjects who completed the study were included in the statistical analysis. |
Arm/Group Title | Pantoprazole | Protonix® |
---|---|---|
Arm/Group Description | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period | Protonix 40 mg DR Tablet (reference) dosed in either period |
Measure Participants | 100 | 100 |
Mean (Standard Deviation) [ng/mL] |
2494.120
(965.022)
|
2747.380
(879.942)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pantoprazole, Protonix® |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Geometric Test/Ref Ratio x 100 |
Estimated Value | 88.8 | |
Confidence Interval |
() 90% 82.7 to 95.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Bioequivalence is established when 90% Confidence Interval falls within 80-125. |
Title | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) |
---|---|
Description | Bioequivalence based on AUC0-inf |
Time Frame | Blood samples collected over 16 hour period |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Pantoprazole | Protonix® |
---|---|---|
Arm/Group Description | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period | Protonix 40 mg DR Tablet (reference) dosed in either period |
Measure Participants | 96 | 99 |
Mean (Standard Deviation) [ng*h/mL] |
6280.022
(6311.033)
|
6332.279
(5923.458)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pantoprazole, Protonix® |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Geometric Test/Ref Ratio x 100 |
Estimated Value | 97.3 | |
Confidence Interval |
() 90% 93.4 to 101 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Bioequivalence is established when 90% Confidence Interval falls within 80-125. |
Title | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) |
---|---|
Description | Bioequivalence based on AUC0-t |
Time Frame | Blood samples collected over 16 hour period |
Outcome Measure Data
Analysis Population Description |
---|
Data from all subjects who completed the study were included in the statistical analysis. |
Arm/Group Title | Pantoprazole | Protonix® |
---|---|---|
Arm/Group Description | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period | Protonix 40 mg DR Tablet (reference) dosed in either period |
Measure Participants | 100 | 100 |
Mean (Standard Deviation) [ng*h/mL] |
5822.470
(4825.928)
|
6016.176
(4502.333)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pantoprazole, Protonix® |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Geometric Test/Ref Ratio x 100 |
Estimated Value | 95.6 | |
Confidence Interval |
() 90% 91.6 to 99.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Bioequivalence is established when 90% Confidence Interval falls within 80-125. |
Adverse Events
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title | Manager, Biopharmaceutics |
---|---|
Organization | Teva Pharmaceuticals USA |
Phone | 1-866-384-5525 |
clinicaltrialqueries@tevausa.com |
- B036581