A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

NCT ID: NCT04039958

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2017-05-28

Brief Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

T test

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Group Type: EXPERIMENTAL

Soviredia

Intervention Type: DRUG

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

B reference (first dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Group Type: ACTIVE_COMPARATOR

Harvoni (first dose)

Intervention Type: DRUG

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

B reference (second dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Group Type: ACTIVE_COMPARATOR

Harvoni (Second dose)

Intervention Type: DRUG

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Interventions

Soviredia

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Intervention Type: DRUG

Harvoni (first dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Intervention Type: DRUG

Harvoni (Second dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Intervention Type: DRUG

Other Intervention Names

Harvoni; Harvoni; Harvoni

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MinaPharm Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Genuine Research Center, Egypt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Elshafeey, Ph.D. Pharma

Role: STUDY_CHAIR

Genuine Research Center

Locations

Genuine Research Center GRC

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 11381568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2004861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3450848 (View on PubMed)

Other Identifiers

GRC/1/17/635

Identifier Type: -

Identifier Source: org_study_id