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A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

NCT04039958 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-31

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 and Ledipasvir from Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.

Conditions

  • Healthy

Interventions

DRUG

Soviredia

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

DRUG

Harvoni (first dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

DRUG

Harvoni (Second dose)

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Sponsors & Collaborators

  • MinaPharm Pharmaceuticals

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2017-05-13
Completion
2017-05-28
FDA Drug
Yes

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 NCT04039958 on ClinicalTrials.gov