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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033055
Receipt No. R000037682
Scientific Title Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug
Date of disclosure of the study information 2018/06/19
Last modified on 2018/12/21

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Basic information
Public title Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug
Acronym Clinical study about IVIVC in poorly soluble basic drug
Scientific Title Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug
Scientific Title:Acronym 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
1st name
Middle name
Last name Takuya Fujita
Organization Ritsumeikan University
Division name College of Pharmaceutical Sciences
Zip code
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
1st name
Middle name
Last name Takuya Fujita
Organization Ritsumeikan University
Division name College of Pharmaceutical Sciences
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 11 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000037682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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