臨床研究等提出・公開システム

Date of registration	Feb. 12, 2020
Last modified on	Nov. 30, 2021
Trial ID	jRCT1080225061

Scientific Title	A bioequivalence study of DS-5565 (mirogabalin besilate) - Evaluation of bioequivalence between milogabalin 15 mg tablet and DS-5565 15 mg orally disintegrating (OD) tablet in healthy Japanese subjects -
Public Title	A bioequivalence study of DS-5565 (mirogabalin besilate) OD tablet

Completion Date or Terminated date	July. 28, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co., Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co., Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		June. 11, 2020
Target Sample Size		72
Study Type		Interventional
Study Design	Study Design	A single-center, randomized, open-label, single dose, two-period, two-way crossover study
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese male 2) Aged 20 years to 45 years (inclusive), at the time of informed consent 3) Body mass index (BMI; calculated by body weight [kg]/height [m]2) in the range of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination
	Exclusion 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.
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Healthy volunteers
Intervention(s)		investigational material(s) Generic name etc : Mirogabalin besilate INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : DS-5565 OD tablet 15 mg, single oral administration control material(s) Generic name etc : Mirogabalin besilate INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Mirogabalin tablet 15 mg, single oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		bioequivalence pharmacokinetics Pharmacokinetic parameters of DS-5565 free base (mirogabalin) in the plasma bioequivalence assessment: Cmax, AUClast
Secondary Outcome		safety pharmacokinetics Pharmacokinetics: Pharmacokinetic parameters of mirogabalin in the plasma Reference parameters: AUCinf, Tmax, MRTinf, Kel Other parameters: t1/2, CL/F, Vz/F, AUCall Safety: adverse event, clinical examination, weight, vital signs (blood pressure, pulse rate, temperature), 12-lead electrocardiogram

Primary Sponsor	DAIICHI SANKYO Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	Feb. 07, 2020

Secondary ID No.	JapicCTI-205156
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Nov. 30, 2021	(this page)	Changes
6	Oct. 01, 2020	Detail	Changes
5	Aug. 06, 2020	Detail	Changes
4	May. 13, 2020	Detail	Changes
3	Mar. 27, 2020	Detail	Changes
2	Feb. 27, 2020	Detail	Changes
1	Feb. 13, 2020	Detail

List of change history