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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Vortioxetine tablet
Nishi Kumamoto Hospital
Kumamoto, Japan
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
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Time frame: Up to Day 25
Number of Participants With TEAE Related to Vital Sign
Time frame: Up to Day 25
Number of Participants With TEAE Related to Clinical Laboratory Tests (Alanine Aminotransferase Increased)
Time frame: Up to Day 25
Number of Participants With TEAE Related to 12-lead Electrocardiograms
Time frame: Up to Day 25