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COMPLETED
NCT07753902
PHASE1

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

Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period, Partially Replicated Bioequivalence Study of Single-Dose ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-04-10

Completion Date

2026-06-12

Last Updated

2026-08-10

Healthy Volunteers

Yes

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.

Locations (1)

Chizhou People's Hospital

Chizhou, Anhui, China