UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015083 |
|---|---|
| Receipt number | R000017549 |
| Scientific Title | Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2021/03/15 10:38:32 |
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Basic information
Public title
Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets
Acronym
Effect of ingested water volume on the pharmacokinetics of drugs
Scientific Title
Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets
Scientific Title:Acronym
Effect of ingested water volume on the pharmacokinetics of drugs
Region
| Japan |
Condition
Condition
digestive disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to make clear the impact of water volume ingested with medicine on the absorption and pharmacokinetic of orally administered drugs. Three kinds of orally disintegrating tablets including acidic, basic and enteric coated drugs are administered with or without water and the blood concentration profile of each drug will be compared.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood concentration profile of each drug after oral administration with or without water ingestion.
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Number of subjects : 12
Period of study: 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered three kinds of drugs (Pitavastatin calcium, Glimepiride, Lansoprazole) orally as OD tablets with water ingestion and then blood is sampled periodically.
Interventions/Control_2
Number of subjects : 12
Period of study: 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered three kinds of drugs (Pitavastatin calcium, Glimepiride, Lansoprazole) orally as OD tablets without water ingestion and then blood is sampled periodically.
Interventions/Control_3
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) Men, Japanese,
If students, this volunteer shop does not affect the required course in their University.
2) BMI is 18.5>= and <25.0.
Key exclusion criteria
1)Who having (or had) a medical history of circulatory system disease, hepatic disease, renal disease, digestive system disease, hematological disorder.
2)Who taking a medicine that night affect the study result.
3)Who judged as inappropriate to this study by the primary doctor of this study from diagnosis, vital signs, inductive electrocardiograph, hematological assessment, blood biochemical test, urinary test, immunological test.
4)Who took a medicine within 7 days before the study
5)Who participated in the clinical trail and took a test medicine within 3 months before the study.
6)Who having (or had) an allergic constitution to medicine/food
7)Who having (or had) a dependency to drug or alcohol
8)Who judged as inappropriate to this study by the primary doctor due to any other reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Yamashita |
Organization
Setsunan University
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
45-1, Nagaotoge-cho, Hirakata, Osaka, Japan
TEL
072-866-3125
shinji@pharm.setsunan.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Yamashita |
Organization
Setsunan University
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
45-1, Nagaotoge-cho, Hirakata, Osaka, Japan
TEL
072-866-3125
Homepage URL
shinji@pharm.setsunan.ac.jp
Sponsor or person
Institute
Faculty of Pharmaceutical Sciences, Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Towa Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Towa Pharmaceutical Co. Ltd.
Name of secondary funder(s)
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
| 2014 | Year | 09 | Month | 08 | 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
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017549
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| Registered date | File name |
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