A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

Healthy Clinical Trial

Official title:

Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005210
• Other study ID #: GRC/1/16/610
• Status: Completed
• Phase: Phase 1
• First received: December 25, 2016
• Last updated: December 28, 2016
• Start date: November 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Genuine Research Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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 Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Magicbuvir Plus
1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
• Harvoni (fist dose)
1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
• Harvoni (second dose)
1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Locations

Country	Name	City	State
Egypt	Genuine Research Center GRC	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Genuine Research Center, Egypt	Magic Pharma, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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.. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal measured plasma concentration (Cmax)	Serial blood samples for determination of study drug will be collected at 0.00, 0.166, 0.33, 0.50, 0.75, 1.00, 1.33, 1.66, 2.00, 2.50, 3.00, 4.00, 6.00, 7.00 , 9.00, 12.00, 24.00, 48.00 and 72.00 hours	Up to 72 hours post dose in each treatment period	No
Secondary	Time of the maximum plasma concentration (Tmax)	The amount of time that a drug is present at the maximum concentration in serum	Up to 72 hours post dose in each treatment period	No

External Links

•   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.
•   Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997