NIPH Clinical Trials Search

Single and multiple doses study of DS-5565 in healthy Chinese subjects

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Healthy volunteers
Date of first enrollment	04/09/2017
Target sample size	54
Countries of recruitment	Asia except Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DS-5565 INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	safety pharmacokinetics Safety and pharmacokinetics
Secondary Outcome	-

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender	Both
Include criteria	1)Healthy Chinese 2)Aged 18 years to 45 years (inclusive), at the time of informed consent 3)Body weight of female >= 45 kg, male >= 50 kg, and a BMI in the range of 19.0 kg/m2 to 26.0 kg/m2 (inclusive) at screening
Exclude criteria	1)Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) 2)Presence or history of any drug abuse or of alcohol abuse etc.