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Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions

NCT07753902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-10

No results posted yet for this study

Summary

This clinical trial aims to evaluate the bioequivalence of a single oral dose of the test drug ADC118 tablets compared with the reference drugs (ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) under fasting conditions in healthy adult Chinese participants. It will also assess the safety of the test drug. The main questions it aims to answer include:

Is the rate and extent of absorption of the test drug ADC118 tablets equivalent to that of the reference drugs?

What adverse events will participants experience while taking the study drugs? Researchers will compare the pharmacokinetic profiles of ADC118 tablets with those of the two reference drugs after a single dose.

Participants will:

Be randomly assigned to one of three treatment sequences (TRR, RTR, or RRT)

In each of the three periods, after an overnight fast of at least 10 hours, take a single dose of the test drug (T) or the reference drug (R) with 240 mL of warm water

Refrain from drinking water (except for the 240 mL taken with the drug) for 1 hour before and after dosing, and not eat any food for 4 hours after dosing

Complete blood sample collection and safety assessments according to the protocol This study plans to enroll 48 healthy participants. It is a single-center, randomized, open-label, three-period crossover trial.

Conditions

  • Human Immunodeficiency Virus (HIV) Infection

Interventions

DRUG

ACC118-Test

Single oral dose of ADC118 tablet, strength: 35 mg ACC017 / 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet.

DRUG

Reference

Single oral dose of the following tablets taken together: Two tablets of ACC017, strength: 20 mg/tablet. One tablet of Emtricitabine/Tenofovir Alafenamide Fumarate Tablets (II), strength: 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet.

Sponsors & Collaborators

  • Jiangsu Aidea Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

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
2026-04-10
Primary Completion
2026-05-18
Completion
2026-06-12

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 NCT07753902 on ClinicalTrials.gov