Japanese Premenopausal Healthy Adult Women Clinical Trial
Official title:
A Phase 1, Randomized, Open-label, Crossover Study to Assess Food Effect on Single Oral Dose Administration of TAK-385 Final Formulation in Premenopausal Healthy Adult Women
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
This is a phase 1 clinical pharmacological study of TAK-385 in Japanese premenopausal healthy
adult women.
Using an open-label crossover design, food effects on the pharmacokinetics and safety of
TAK-385 will be evaluated in participants receiving a single oral dose of TAK-385 40 mg in
fasted condition without breakfast, before breakfast, or after breakfast.
Participants determined to be eligible will be randomly assigned to one of Groups A to F
prior to study medication administration in Period 1; subsequently, participants will receive
one TAK-385 40 mg tablet in fasted condition without breakfast (following a minimum 10-hour
overnight fast), before breakfast (30 minutes before starting breakfast), or after breakfast
(30 minutes after starting breakfast) in Periods 1, 2, and 3.
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