Healthy Adult Participants Clinical Trial
Official title:
A Randomized, Open-Label, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of Single Oral Dose of Lu AA21004 20 mg Tablet and 2× Lu AA21004 10 mg Tablets in Healthy Adult Subjects
The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.
The drug being tested in this study is called vortioxetine (Lu AA21004). Vortioxetine is
being tested in Japanese healthy adult participants. This study will look at the
bioequivalence of a single oral administration of a vortioxetine 20 mg tablet in comparison
with two of vortioxetine 10 mg tablets, and also look at the safety of a single oral dose of
vortioxetine 20 mg in Japanese healthy adult participants.
The study will enroll 28 (14 for each sequence) healthy participants. In case bioequivalence
cannot be demonstrated with the number of participants initially planned, an add-on
participant study may be conducted (as a maximum 28 participants additionally). Participants
will be randomly assigned (by chance, like flipping a coin) to one of the two treatment
groups.
- Treatment Group A: Vortioxetine 20 mg (one 20 mg tablet) in Period 1 + Vortioxetine 20
mg (two 10 mg tablets) in Period 2
- Treatment Group B: Vortioxetine 20 mg (two 10 mg tablets) in Period 1 + Vortioxetine 20
mg (one 20 mg tablet) in Period 2
This single-center trial will be conducted in Japan. The overall time to participate in this
study is approximately 25 days. Participants will make two visits to the clinic and be
hospitalized for ten days in total.
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