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

NCT02491450 | Completed Phase 1

• 1 other identifier: GRC/1/15/562
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Maximal measured plasma concentration (Cmax)

  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

  Up to 72 hours post dose in each treatment period

Secondary Outcomes (1)

• (tmax)

  Up to 72 hours post dose in each treatment period

Study Arms (2)

A Test

EXPERIMENTAL

Test drug (Heterosofir)1 tablet contains 400 mg Sofosbuvir

Drug: Heterosofir

B Reference

ACTIVE COMPARATOR

Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir

Drug: Sovaldi

Interventions

Heterosofir DRUG

1 tablet contains 400 mg sofosbuvir

Also known as: Sovaldi

A Test

Sovaldi DRUG

1 tablet contains 400 mg sofosbuvir

B Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Subject does not have allergy to the drugs under investigation.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects whose values of BMI were outside the accepted normal ranges.
• Female subjects who were pregnant, nursing or taking birth control pills.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• 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.
• Subject is on a special diet (for example subject is vegetarian).
• 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.
• 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.
• Subject has a history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
• Subject intends to be hospitalized within 3 months after first study drug administration.
• 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.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Pharmed Healthcare, Egypt: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, Egypt

Location

Related Links

• 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

MeSH Terms

Interventions

Sofosbuvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

EG (1)