臨床研究等提出・公開システム

Date of registration	Aug. 18, 2017
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080223619

Scientific Title	DK-233(Rifampicin) Bioequivalence study -Bioequivalence of DK-233 150 mg capsules and DK-233 20 mg/ml syrup in healthy Japanese subjects-
Public Title

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

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

Recruitment Status

Date of First Enrolment
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, randomized, single-dose, two-period, two-way crossover study
Study Design	Objective
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 : DK-233 syrup INN of investigational material : rifampicin Therapeutic category code : 616 Antibiotic preparations acting mainly on acid-fast bacteria Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : DK-233 capsule INN of investigational material : rifampicin Therapeutic category code : 616 Antibiotic preparations acting mainly on acid-fast bacteria Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Pharmacokinetics and safety
Secondary Outcome

Primary Sponsor	DAIICHI SANKYO CO., LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	refer to Japanese
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-173675
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	April. 02, 2018	Detail	Changes
5	April. 02, 2018	Detail	Changes
4	Dec. 04, 2017	Detail	Changes
3	Dec. 04, 2017	Detail	Changes
2	Aug. 18, 2017	Detail	Changes
1	Aug. 18, 2017	Detail

List of change history