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Pharmacokinetics of Two Formulation of Tenofovir Disoproxil Fumarate

NCT04671563 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-12-17

No results posted yet for this study

Summary

To evaluate pharmacokinetic profiles of Viproof Film Coated Tablets 300 mg manufactured by Yung Shin Parm. Ind. Co., Ltd., Taiwan and Viread Tablets manufactured by Patheon, Inc. in terms of plasma concentrations of tenofovir after a single oral dose of 300 mg tenofovir disoproxil fumarate in healthy subjects under fasting conditions.

Conditions

  • Pharmacokinetic of Tenofovir in Healthy Subjects

Interventions

DRUG

Tenofovir Disoproxil Fumarate 300 MG

One tablet of Viproof Film Coated Tablets or Viread Tablets will be orally administrated with 240 mL of water in the morning.

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    collaborator OTHER

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-05-09
Completion
2020-08-31

Countries

  • Taiwan

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 NCT04671563 on ClinicalTrials.gov