A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sofodelevier; Drug: Sovaldi (fist dose); Drug: Sovaldi (second dose)

• Registration Number: NCT03062423
• Lead Sponsor: Genuine Research Center, Egypt

Brief Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier 400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T test	Sofodelevier	Test drug (Sofodelevier)1 tablet contains 400 mg Sofosbuvir
B reference (first dose)	Sovaldi (fist dose)	Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir
B reference (second dose)	Sovaldi (second dose)	Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir

Primary Outcome Measures

Name	Time	Method
Maximal measured plasma concentration (Cmax)	Up to 7 hours post dose in each treatment period	Serial blood samples for determination of study drug will be collected at 0, 00, 0,166, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours

Secondary Outcome Measures

Name	Time	Method
Time of the maximum plasma concentration (Tmax)	Up to 7 hours post dose in each treatment period	The amount of time that a drug is present at the maximum concentration in serum

Trial Locations

Locations (1)

Genuine Research Center GRC; 🇪🇬 Cairo, Egypt