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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)

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ClinicalTrials.gov Identifier: NCT02507648
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
Pharmacare PLC, Palestine
Information provided by (Responsible Party):
Genuine Research Center, Egypt

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oseltamivir Drug: Tamiflu® Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 Start Date : March 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Test
Test drug (Oseltamivir) 1 tablet contains 75 mg Oseltamivir
Drug: Oseltamivir
1 tablet contains 75 mg oseltamivir
Other Name: Tamiflu®

Active Comparator: B Reference
Reference drug (Tamiflu®) 1 tablet contains 75 mg Oseltamivir
Drug: Tamiflu®
1 tablet contains 75 mg oseltamivir




Primary Outcome Measures :
  1. To demonstrate bioequivalence between (Test Product) Oseltamivir 75 mg per capsules and the corresponding (Reference Product) Tamiflu® 75 mg Oseltamivir per capsules [ Time Frame: Up to 12 hours post dose in each treatment period ]
    Serial blood samples for determination of study drug will be collected at 0,00( pre-dose), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, and 12.00 hours


Secondary Outcome Measures :
  1. To measure Cmax [ Time Frame: Up to 12 hours post dose in each treatment period ]
    Cmax (Maximum observed concentration)

  2. To measure AUC [ Time Frame: Up to 12 hours post dose in each treatment period ]
    AUC (Area under the concentration-time curve)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507648


Locations
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Egypt
Genuine Research Center GRC
Cairo, Egypt
Sponsors and Collaborators
Genuine Research Center, Egypt
Pharmacare PLC, Palestine
Investigators
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Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
Additional Information:
Publications:
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Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT02507648    
Other Study ID Numbers: GRC 1/12/01CAREOSELT
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action