臨床研究等提出・公開システム

Date of registration	Dec. 22, 2016
Last modified on	May. 20, 2020
Trial ID	jRCT1080223420

Scientific Title	Bioequivalence of DS-5058b (extended-release tablet) to oxycodone hydrochloride hydrate in healthy Japanese subjects
Public Title	DS-5058b (extended-release tablet) bioequivalence study

Completion Date or Terminated date	May. 04, 2014
Actual Enrolled Number	48
Baseline Characteristics	The subject demographics and characteristics for the safety analysis set was identical to those for the pharmacokinetic analysis set.
Participant flow	A total of 48 subjects who were confirmed to be eligible were enrolled after obtaining informed consent for the study. One subject withdrew from the study.
Adverse events	- Treatment emerged adverse events (TEAEs) for DS-5058b and reference drug under fasting conditions were reported in 4 of 3 subjects and 5 of 4 subjects, respectively. - TEAEs for DS-5058b and reference drug under fed conditions were reported in 6 of 5 subjects and 6 of 5 subjects, respectively. - No death nor serious adverse event was reported. - TEAEs leading to study discontinuation occurred in 1 subject. The event was assessed as being unrelated to the 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 AUCt were within the bioequivalence criteria (0.80-1.25) under both fasting and fed conditions.
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 AUCt were within the bioequivalence criteria (0.80-1.25) under both fasting and fed conditions. Therefore, DS-5058b (extended-release tablet) was judged to be bioequivalent to the reference drug. There was no meaningful difference in TEAE between 10 mg DS-5058b (extended-release tablet) and reference drug under both fasting and fed conditions, 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	May. 17, 2017
URL hyperlink(s) related to results and publications	https://link.springer.com/article/10.1007%2Fs40268-017-0184-x

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		Mar. 31, 2014
Target Sample Size		48
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	- Male Japanese - Between the age of 20 and 45 - Between the BMI of 18.5 and 24.9
	Exclusion Criteria	- Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug. - Presence or history of 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 hydrate Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Single oral administration, 10 mg control material(s) Generic name etc : Oxycodone hydrochloride hydrate INN of investigational material : Oxycodone hydrochloride hydrate Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Single oral administration, 10 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	Feb. 28, 2014

Secondary ID No.	JapicCTI-163475
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	May. 20, 2020	(this page)	Changes
3	Dec. 17, 2018	Detail	Changes
2	Dec. 22, 2016	Detail	Changes
1	Dec. 22, 2016	Detail

List of change history