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)
NCT ID: NCT05491330
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2022-08-21
2022-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants
NCT06397144
A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804
NCT01313793
Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)
NCT03071380
Bioequivalence Study Of Verapamil
NCT00668967
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study
NCT03602300
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
R reference (first dose)
Reference drug (Paxlovid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets
Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
T test
Test drug (Copaxid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets
Nirmatrelvir 150 mg + Ritonavir 100 mg (test)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
R reference (second dose)
Reference drug (Paxlovid) Nirmatrelvir 150 mg + Ritonavir 100 mg tablets
Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Nirmatrelvir 150 mg + Ritonavir 100 mg (test)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
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. Females should be on a suitable birth control method.
6. Fully informed subjects that consented to participate in the study.
Exclusion Criteria
2. Female subjects who were pregnant or nursing.
3. Acute infection within one week preceding first study drug administration.
4. History of drug or alcohol abuse.
5. 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.
6. Subject is on a special diet (for example subject is vegetarian).
7. 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.
8. 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.
9. Subject has a family history of severe diseases which have direct impact on the study.
10. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.
11. Subject intends to be hospitalized within 3 months after first study drug administration.
12. Subjects who have donated blood or lost more than 500 mL blood within 3 months prior to the study.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eva Pharma
INDUSTRY
Genuine Research Center, Egypt
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Elshafeey, Ph.D. Pharma
Role: STUDY_DIRECTOR
Genuine Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Genuine Research Center GRC
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
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. doi: 10.1007/BF01068419.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GRC/1/22/1038
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.