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A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu� 75 mg Caps (Hoffmann-La Roche, Switzerland)

Information source: Genuine Research Center, Egypt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oseltamivir (Drug); Tamiflu® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Genuine Research Center, Egypt

Official(s) and/or principal investigator(s):
Ahmed Elshafeey, Ph.D. Pharma, Study Director, Affiliation: Genuine Research Center

Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and Tamiflu 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences ,California ,USA after a single oral dose administration of each to healthy adults under fasting conditions.

Clinical Details

Official title: Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu 75 mg Caps (Hoffmann-La Roche, Switzerland)

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: To demonstrate bioequivalence between (Test Product) Oseltamivir 75 mg per capsules and the corresponding (Reference Product) Tamiflu® 75 mg Oseltamivir per capsules

Secondary outcome:

To measure Cmax

To measure AUC

Detailed description: Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80. 00-125. 00%. A comprehensive final report will be issued upon the completion of the study.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Healthy male or female, age 18 to 55 years, inclusive. 2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI). 3. Medical demographics without evidence of clinically significant deviation from normal medical condition. 4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator. 5. Subject does not have allergy to the drugs under investigation. Exclusion Criteria: 1. Subjects with known allergy to the products tested. 2. Subjects whose values of BMI were outside the accepted normal ranges. 3. Female subjects who were pregnant, nursing or taking birth control pills. 4. Medical demographics with evidence of clinically significant deviation from normal medical condition. 5. Results of laboratory tests which are clinically significant. 6. Acute infection within one week preceding first study drug administration. 7. History of drug or alcohol abuse. 8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study. 9. Subject is on a special diet (for example subject is vegetarian). 10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e. g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period. 11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study. 12. Subject has a history of severe diseases which have direct impact on the study. 13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration. 14. Subject intends to be hospitalized within 3 months after first study drug administration. 15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.

Locations and Contacts

Genuine Research Center GRC, Cairo, Egypt
Additional Information

Description: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997

Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products- General Considerations. US Dept. of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)

Note for Guidance on Clinical Safety Data Management; Definitions And Standards for Expedited Reporting (CPMP/ICH/377/95) The European Agency for the Evaluation of Medicinal Products (EMEA) June 1995.

International conference of Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996

Related publications:

Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. Erratum in: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101..

Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80.

Starting date: March 2013
Last updated: July 23, 2015

Page last updated: August 23, 2015

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