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drugset / Trial / NCT05316259

A Food-Effect Study of BPI-16350 in Healthy Subjects

NCT05316259 ↗

Phase 1 Completed 24 enrolled Betta Pharmaceuticals Co., Ltd.
RandomizedCrossoverOpen-labelBasic science

Summary

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).

Timeline

Start
2022-04-15
Primary completion
2022-08-30
Completion
2022-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject tibremciclib Small molecule — Oral

Indications

No indication recorded.