Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-438ASA Tablet and Single Oral Dose of TAK-438 Tablet Plus Aspirin Enteric-Coated Tablet (Study 1) and the Food Effect of Single Oral Dose of TAK-438ASA Tablet (Study 2) in Healthy Adult Male Subjects
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).
The drug under investigation in this study is called TAK-438ASA. TAK-438ASA is being tested
in Japanese healthy adult men. This study consists of two studies to evaluate bioequivalence
(Study 1) and the effects of food (Study 2). Study 1 (split into a Pilot phase and a Pivotal
phase) will look at bioequivalence between a single-dose of TAK-438ASA tablet versus a
single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated tablet 100 mg.
Study 2 will look at the effects of food on the pharmacokinetics of TAK-438ASA tablet.
The study will enroll up to 440 participants in total (Study 1 + 2). For Study 1, 12
participants per group (24 participants in total) will be randomly assigned (by chance, like
flipping a coin) to one of the two treatment groups for the pilot study to estimate the
sample size of Pivotal study. After pilot study, 202 participants as a maximum per group (404
participants in total) will be randomly assigned to one of the two treatment groups:
- TAK-438ASA tablet (Period 1) + TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 2)
- TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 1) + TAK-438ASA tablet (Period 2)
For Study 2, 6 participants per group (12 participants in total) will be randomly assigned
(by chance, like flipping a coin) to one of the two treatment groups:
- TAK-438ASA tablet (Fasted condition) + TAK-438ASA tablet (Fed condition)
- TAK-438ASA tablet (Fed condition) + TAK-438ASA tablet (Fasted condition) This
single-center trial will be conducted in Japan. The overall time to participate in this
study is approximately 18 days. Participants will make two visits to the clinic and be
hospitalized for eight days in total.
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