Bioequivalence Clinical Trial
Official title:
A Phase I, Open-Label, Randomized, 2-Treatment, 2-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule
This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.
Eligible healthy participants will be randomized to receive either treatment sequence 1 (AB) or treatment sequence 2 (BA), as follows: - Treatment A: Acalabrutinib tablet, 100 mg, fasted state - Treatment B: Acalabrutinib capsule, 100 mg, fasted state Participants will receive fixed single doses of acalabrutinib on 2 occasions, under fasted conditions. The study will comprise: - Visit 1: A screening period of up to 28 days before first dosing. - Visit 2: Two treatment periods: - Participants will be admitted to the study center on Day -2 of Treatment Period 1 to confirm eligibility before first dosing. Eligibility criteria will be reconfirmed on Day -1 of each treatment period. - On Day 1 of Treatment Periods 1 and 2, participants will be administered the assigned treatment (A or B) as randomized, followed by a protocol defined washout period between Treatment Periods 1 and 2. - Visit 3: A Follow-up Visit/Early Termination Visit at 7 to 10 days after last administration of study drug. Each participant will be involved in the study for approximately 6 weeks. ;
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