NCT04671563

Pharmacokinetics of Two Formulation of Tenofovir Disoproxil Fumarate

A Randomized, Single-Dose, Parallel-Group Study to Evaluate thePharmacokinetic Profiles of Two Formulations of Tenofovir Disoproxil Fumarate After Oral Administration in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-05-09
• Completion: 2020-08-31
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: Taiwan