Unique ID issued by UMIN | UMIN000002739 |
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Receipt number | R000003331 |
Scientific Title | The pharmacokinetic study of drug interaction between metformin and pyrimethamine from microdose to clinical dose in adult healthy volunteers |
Date of disclosure of the study information | 2009/11/13 |
Last modified on | 2010/05/06 13:32:46 |
The pharmacokinetic study of drug interaction between metformin and pyrimethamine from microdose to clinical dose in adult healthy volunteers
The drug interaction study between metformin and pyrimethamine
The pharmacokinetic study of drug interaction between metformin and pyrimethamine from microdose to clinical dose in adult healthy volunteers
The drug interaction study between metformin and pyrimethamine
Japan |
healthy male subjects
Not applicable |
Others
YES
To evaluate the pharmacokinetics in vivo in healthy volunteers of metformin in a single dose from microdose to clinical dose with or without pyrimethamine
Pharmacokinetics
Pharmacokinetic parameters in plasma
Interventional
Single arm
Non-randomized
Open -no one is blinded
Dose comparison
1
Treatment
Medicine |
four terms
Phase 1(washout 1week)-phase2(washout 3weeks)-phase3(washout 1week)-phase4
phase1 metformin(MD)
Phase2 metformin(MD) and pyrimethamine
Phase3 metformin(CD)
Phase4 metformin(CD) and pyrimethamine
single dose in each term
20 | years-old | <= |
35 | years-old | > |
Male
1) Ability to understand and willing to sign the informed consent.
2) Japanese healthy male subjects age 20 to 35 years of age
3) Body Mass Index (BMI):18.5~28.5
4) good health as determined by physical examination, vital signs and laboratory tests.
1) Any medical condition that requires medical attention
2) Impairments of liver or kidney functions
3) Dysemia and history of this disease
4) Cardiac disease or respiratory disease and history of them
5) Any hypersensitivity to pyrimethamine or metformin
6) Use of medicine or health product including Saint John's wort 2 weeks before pre-dose.
7) Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose.
8) Participation to any other clinical research in the past 3 months.
9)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
10) Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
11) Any allergy to drug and food
12) history of drug or alcohol abuse
13) Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study
8
1st name | |
Middle name | |
Last name | Yuji Kumagai |
Kitasato University East Hospital
Clinical trial Center
2-1-1, Asamizodai, Sagamihara, Kanagawa, 228-8520
1st name | |
Middle name | |
Last name |
Kitasato University East Hospital
Clinical trial Center
2-1-1, Asamizodai, Sagamihara, Kanagawa, 228-8520
Clinical trial Center,Kitasato University East Hospital
APDD, Association for Promoting Drug Development
NO
2009 | Year | 11 | Month | 13 | Day |
Unpublished
Completed
2009 | Year | 10 | Month | 30 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2009 | Year | 11 | Month | 10 | Day |
2010 | Year | 05 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003331
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