This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of Befotertinib capsules in healthy trial participants. The study consists of two treatment groups. The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin. The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of Befotertinib capsules. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGMaximum plasma concentration (Cmax)
Time frame: From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Time frame: From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Time frame: From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
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