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Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects

NCT07558967 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-04-30

No results posted yet for this study

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

Conditions

  • Healthy

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

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2017-08-23
Completion
2017-11-20

Countries

  • China

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 NCT07558967 on ClinicalTrials.gov