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.
Age range
18 Years – 55 Years
Sex
ALL
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PK Parameter: Cmax
Timeframe: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
PK Parameter: AUC0-t
Timeframe: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
PK Parameter: AUC0-∞
Timeframe: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period