NCT03437564

A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine tablet

Timeline

• Start date: 2018-02-16
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2018-02-19
• Last updated: 2019-06-27
• Results posted: 2019-06-26

Locations

1 site across 1 country: Japan