A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants
brief summary
A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.
detailed description
On Day 1 and Day 11 of the trial, HS-10506 tablets will be orally administered under fasting conditions in the morning. From Day 7 to Day 15, itraconazole capsules (0.2 g, administered as two 0.1 g capsules) will be taken orally once daily for nine consecutive days. On the morning of Day 11, itraconazole capsules and HS-10506 tablets will be taken concurrently. When administered alone or in combination with itraconazole capsules, HS-10506 tablets will be given under fasting conditions. When administered alone, itraconazole capsules will be taken within 15 minutes after a meal, with approximately 240 mL of water.