UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033055 |
|---|---|
| Receipt number | 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 11:43:15 |
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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
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
fujita-t@ph.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037682
