A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
A two-phase study design will be used for this pilot study. In the first phase, a 2×2
crossover study will be used to evaluate the safety, tolerability and PK characteristic of
APL-1202 and APL-1501 ER Tablets 3. Twelve healthy subjects will be in ratio 1:1 randomly
assigned to two groups, randomization will be stratified by gender (male, female) in ratio
1:1. Each group will be dosed with APL-1202, APL-1501 ER Tablets 3 in a cross-over way. A
7-day (±1 day) washout will be required before next period of drug administration. The
samples in first phase will be sent to bioanalysis lab for PK research at the end of first
phase. The initiate of second phase will depend on the results of first phase within 30 days
and not less than 7 days after the first phase.