Japanese Healthy Adult Male Clinical Trial
Official title:
A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese healthy adult male participants.
The drug being tested in this study is called TAK-438 OD tablet. TAK-438 OD tablet is being
tested in Japanese healthy adult men. This study will evaluate bioequivalence of single oral
dose of TAK-438 OD 20 mg tablet without water and TAK-438 20 mg tablet with water (Study 1),
and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2).
The study will enroll up to 144 participants in total (Study 1 + 2). In Study 1 and 2,
participants will be randomly assigned (by chance, like flipping a coin) to one of the two
treatment groups;
Study 1:
- TAK-438 OD 20 mg tablet without water (Period 1) + TAK-438 20 mg tablet with water
(Period 2)
- TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet without water
(Period 2)
Study 2:
- TAK-438 OD 20 mg tablet with water (Period 1) + TAK-438 20 mg tablet with water (Period
2)
- TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet with water (Period
2)
This single-center trial will be conducted in Japan. The overall time to participate in this
study is approximately 11 days. Participants will make two visits to the clinic and be
hospitalized for four days each in Periods 1 and 2.
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