UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug
Title of the study (Brief title)	Clinical study about IVIVC in poorly soluble basic drug
Region	Japan

Condition
Condition	Healthy male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Albendazole tablet, acetaminophen syrup, diluted hydrochloric acid and methacrylic acid copolymer LD are administered by 3 group 3 period crossover for fasting single oral cassette dose. We compare with their plasma concentrations.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics of albendazole and albendazole sulfoxide
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single oral administration of albendazole and acetaminophen
Interventions/Control_2	Single oral administration of albendazole, acetaminophen and diluted hydrochloric acid
Interventions/Control_3	Single oral administration of albendazole, acetaminophen, diluted hydrochloric acid and methacrylic acid copolymer LD
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	1. Healthy Japanese male subjects who provide signed written informed consent. 2. Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3. Subjects with BMI <=18.5 and >25.0 at the time of screening. 4. Subjects judged as adequate for this study by study physician.
Key exclusion criteria	1. Subjects who had gastrointestinal resection and vagotomy 2. Subjects with present illness which requires treatment. 3. Subjects with past medical history which was considered not adequate for this study. 4. Subjects with past history of drug allergy. 5. Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission of period 1. 6. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200 mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1. 7. Subjects who participated in a clinical trial and was administered study drug within 16 weeks prior to admission of period 1. 8. Subjects with history of alcohol and/or drug abuse. 9. Subjects who were judged not appropriate for this study by study physician.
Target sample size	18

Research contact person
Name of lead principal investigator	Takuya Fujita
Organization	Ritsumeikan University
Division name	College of Pharmaceutical Sciences
Address	1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577 JAPAN
TEL	077-561-5974
Email	fujita-t@ph.ritsumei.ac.jp

Public contact
Name of contact person	Takuya Fujita
Organization	Ritsumeikan University
Division name	College of Pharmaceutical Sciences
Address	1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577 JAPAN
TEL	077-561-5974
Homepage URL
Email	fujita-t@ph.ritsumei.ac.jp

Sponsor
Institute	Ritsumeikan University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Towa Pharmaceutical co., ltd., JAPAN TOBACCO INC., Asahi Kasei Pharma Corporation., SHIONOGI & CO., LTD., ONO PHARMACEUTICAL CO., LTD., DAIICHI SANKYO RD NOVARE CO., LTD., DAIICHI SANKYO CO., LTD. Sawai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. , Japan Machinery Company
Name of secondary funｄer(s)	Same as above

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人相生会 博多クリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 19 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037682