A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)

• Sponsor: Genuine Research Center, Egypt (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02491450
• Collaborator: Pharmed Healthcare, Egypt (Other)
• Enrollment: 24
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human Volunteers Under Fasting Condition.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Heterosofir; Drug: Sovaldi	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Test Test drug (Heterosofir)1 tablet contains 400 mg Sofosbuvir	Drug: Heterosofir; 1 tablet contains 400 mg sofosbuvir; Other Names: Sovaldi
Active Comparator: B Reference Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir	Drug: Sovaldi; 1 tablet contains 400 mg sofosbuvir

Outcome Measures

Primary Outcome Measures

1. Maximal measured plasma concentration (Cmax) [Up to 72 hours post dose in each treatment period]

   Serial blood samples for determination of study drug will be collected at 0,00( pre-dose), 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, 7.00, 9.00, 12.00, 24.00, 48.00 & 72.00 hours post-dose

Secondary Outcome Measures

1. (tmax) [Up to 72 hours post dose in each treatment period]

   Time of the maximum plasma concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genuine Research Center GRC	Cairo		Egypt

Sponsors and Collaborators

• Genuine Research Center, Egypt
• Pharmed Healthcare, Egypt

Investigators

• Study Director: Ahmed Elshafeey, Ph.D. Pharma, Genuine Research Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• International conference of Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996

Publications

None provided.

• Responsible Party: Genuine Research Center, Egypt
• ClinicalTrials.gov Identifier: NCT02491450
• Other Study ID Numbers: GRC/1/15/562
• First Posted: Jul 8, 2015
• Last Update Posted: Jul 8, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Sofosbuvir

Study Results

No Results Posted as of Jul 8, 2015