Overview

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

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Genuine Research Center, Egypt
Collaborator:
Pharmed Healthcare, Egypt
Treatments:
Sofosbuvir
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.