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COMPLETED
NCT07558967
PHASE1

Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This study evaluated the bioequivalence and safety of the test formulation (Tenofovir Disoproxil Fumarate Tablets, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (Viread®, Gilead Sciences, Inc.) in healthy Chinese subjects under fasting and fed conditions

Official title: Bioequivalence and Safety Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: a Randomized, Open-label, Single-dose, Crossover Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2017-06-20

Completion Date

2017-11-20

Last Updated

2026-04-30

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Test Tenofovir Disoproxil Fumarate Tablets

Test formulation(Tenofovir Disoproxil Fumarate Tablets,Haisco Pharmaceutical Group Co., Ltd),A single oral dose of 300 mg, taken with 240mL of water

DRUG

Reference Tenofovir Disoproxil Fumarate Tablets(Viread®)

Reference formulation(Viread®,Gilead Sciences, Inc.)A single oral dose of 300 mg, taken with 240mL of water

Locations (1)

General Hospital of Shenyang Military Region

Shenyang, China