臨床研究等提出・公開システム

Date of registration	Nov. 30, 2017
Last modified on	May. 20, 2020
Trial ID	jRCT1080223737

Scientific Title	A Bioequivalence study of DS-5058b (immediate-release tablet) and oxycodone hydrochloride hydrate in healthy Japanese subjects
Public Title	A Bioequivalence study of DS-5058b (immediate-release tablet) and oxycodone hydrochloride hydrate in healthy Japanese subjects

Completion Date or Terminated date	Mar. 02, 2018
Actual Enrolled Number	31
Baseline Characteristics	The subject demographics and characteristics for the safety analysis set was similar to those for the pharmacokinetic analysis set.
Participant flow	A total of 31 subjects who were confirmed to be eligible were enrolled after obtaining informed consent for the study, Eight subjects withdrew from the study.
Adverse events	- Treatment emerged adverse events (TEAEs) for DS-5058b and reference drug were reported in 14 of 7 subjects and 5 of 3 subjects, respectively. - No death nor serious adverse event was reported. - TEAEs leading to study discontinuation occurred in 2 of 1 subject. The events were assessed as being unrelated to treatment. - No clinically relevant changes from baseline were seen in laboratory parameters, vital signs, 12-lead ECG parameters, or body weight, except for the abnormal change in the laboratory values reported as TEAEs. In addition, there was also no concern related to the drug dependency.
Primary Outcome Measures	The ratio of geometric least-square means and 90% CI for Cmax and AUCall were within the bioequivalence criteria (0.80-1.25), respectively.
Secondary Outcome Measures	Please refer to "adverse events" section since secondary outcome measures in the study are safety.
Brief summary	The ratio of geometric least-square means and 90% CI for Cmax and AUCall were within the bioequivalence criteria (0.80-1.25). DS-5058b (immediate-release tablet) was judged to be bioequivalent to the reference drug. - There was no meaningful difference in TEAE between 5 mg DS-5058b (immediate-release tablet) and reference drug, and no safety concern was noted in single oral administration of both drugs.
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		Dec. 12, 2017
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, randomized, single-dose, two-period, two-way crossover study
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese male - Between the age of 20 and 45 - Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2
	Exclusion Criteria	- Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) - People with drug or alcohol dependence. 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 : DS-5058b INN of investigational material : Oxycodone Hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Single oral administration, 5 mg control material(s) Generic name etc : Oxycodone hydrochloride hydrate INN of investigational material : Oxycodone Hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Single oral administration, 5 mg
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacokinetics - Pharmacokinetics
Secondary Outcome		safety - Safety

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

Name of Funding Organization	-
Name of Research Funding	-

Name	-
Address	-
Phone Number	-
E-mail Address	-
Status of Review	Approval
Date of Approval	Nov. 17, 2017

Secondary ID No.	JapicCTI-173793
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	May. 20, 2020	(this page)	Changes
7	Dec. 17, 2018	Detail	Changes
6	Sept. 07, 2018	Detail	Changes
5	Sept. 07, 2018	Detail	Changes
4	April. 20, 2018	Detail	Changes
3	April. 20, 2018	Detail	Changes
2	Nov. 30, 2017	Detail	Changes
1	Nov. 30, 2017	Detail

List of change history