A bioequivalence study of ACT-541468 25 and 50mg tablet

JRCT ID: jRCT2071220009

Registered date:19/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 17/05/2022
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Administration of ACT-541468 50mg once daily

Outcome(s)

• Primary Outcome: Cmax, AUC0-t

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

(1) Signed informed consent for participation in the study prior to any study-mandated procedure.
(2) Male Japanese aged 20 to 40 (inclusive) years at the time of informed consent
(3) No relevant abnormalities on physical examination at screening and Pre-dose of Day 1 of Period 1.
(4) BMI 18.5 to 25.0 kg/m2 at screening.
(5) Blood pressure and pulse rate measured after 5 min in the supine position meet the following criteria at screening and Pre-dose of Day 1 of Period 1.
Systolic blood pressure: 90 - 140 mmHg
Diastolic blood pressure: 40 - 90 mmHg
Pulse rate: 40-100 beats/min

Exclude criteria

(1) Known hypersensitivity to study drug or drugs of the same class, or any of the excipients of the drug formulation.
(2) Known hypersensitivity or allergy to natural rubber or latex.
(3) Previous relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
(4) Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
(5) Treatment with another investigational drug within 4 months prior to screening or having participated in more than three investigational drug studies within 1 year prior to screening.
(6) History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
(7) History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study drug (appendectomy and herniotomy allowed; cholecystectomy not allowed).

Related Information

• Primary Sponsor: Kawashima Takayuki
• Secondary Sponsor: Mochida Pharmaceutical Co., Ltd.