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A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)

NCT02605798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-16

No results posted yet for this study

Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus Sovaldi 400 mg Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United Kingdom)

Conditions

  • Healthy

Interventions

DRUG

Elbanovir

1 tablet contains 400 mg sofosbuvir

DRUG

Sovaldi

1 tablet contains 400 mg sofosbuvir

DRUG

Sovaldi

1 tablet contains 400 mg sofosbuvir

Sponsors & Collaborators

  • Multi-Apex Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605798 on ClinicalTrials.gov