Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
Study Details
Study Description
Brief Summary
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Primary Pharmacokinetic Parameters: Cmax, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: R reference (first dose) Reference drug (Paxlovid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets |
Drug: Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Other Names:
|
| Experimental: T test Test drug (Copaxid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets |
Drug: Nirmatrelvir 150 mg + Ritonavir 100 mg (test)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Other Names:
|
| Active Comparator: R reference (second dose) Reference drug (Paxlovid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets |
Drug: Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax [Up to 48 hours post dose in each treatment period]
Maximal measured plasma concentration
Secondary Outcome Measures
- Time of the maximum plasma concentration (Tmax) [Up to 48 hours post dose in each treatment period]
The amount of time that a drug is present at the maximum concentration in serum
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male or female, age 18 to 55 years, inclusive.
-
Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
-
Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
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Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
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Females should be on a suitable birth control method.
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Fully informed subjects that consented to participate in the study.
Exclusion Criteria:
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Subjects with known allergy to the products tested.
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Female subjects who were pregnant or nursing.
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Acute infection within one week preceding first study drug administration.
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History of drug or alcohol abuse.
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Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
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Subject is on a special diet (for example subject is vegetarian).
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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.
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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.
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Subject has a family history of severe diseases which have direct impact on the study.
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Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
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Subject intends to be hospitalized within 3 months after first study drug administration.
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Subjects who have donated blood or lost more than 500 mL blood within 3 months prior to the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genuine Research Center GRC | Cairo | Egypt | 11757 |
Sponsors and Collaborators
- Genuine Research Center, Egypt
- Eva Pharma
Investigators
- Study Director: Ahmed Elshafeey, Ph.D. Pharma, Genuine Research Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997
- 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.
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.
- GRC/1/22/1038