Unique ID issued by UMIN | UMIN000024027 |
---|---|
Receipt number | R000027667 |
Scientific Title | Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects. |
Date of disclosure of the study information | 2017/02/26 |
Last modified on | 2017/12/20 12:36:57 |
Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects.
Study of XO/XDH inhibitors and inosine in healthy subjects
Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects.
Study of XO/XDH inhibitors and inosine in healthy subjects
Japan |
Healthy subjects
Adult |
Others
NO
To examine the changes of purine compounds in the blood by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine.
Safety,Efficacy
Exploratory
Others
Changes of purine compounds in the blood
1. Comparisons of means of purine compounds before and after treatment in each group.
2. Comparisons of means of changes of purine compounds between groups.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
Allopurinol 100 mg and inosine 0.5 g twice a day for 14 days
Topiroxostat 60 mg and inosine 0.5 g twice a day for 14 days
Topiroxostat 80 mg and inosine 0.5 g twice a day for 14 days
Febuxostat 20 mg and inosine 0.5 g twice a day for 14 days
20 | years-old | <= |
40 | years-old | >= |
Male
1) Healthy adult Japanese male
2) Subject with the ability to express his consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his consent to participate in the present clinical study.
3) Japanese subject with the age on the day of informed consent of not lower than 20 and not higher than 40.
4) Subject whose BMI is not lower than 17.6 and lower than 26.5 on the day of screening).
1) Routine user of medicine or supplement.
2) Subject who is currently being treated.
3) Subject who has or had renal function disorder.
4) Subject with a history of gout, hyperuricemia or urolithiasis.
5) Subject who has a history of renal disorder.
6) Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
7) Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function that are considered to affect absorption, distribution, metabolism or excretion of a drug.
8) Subject who participated in another clinical study for a drug with a new compound within 4 weeks before the administration of drug in the present sduty.
9) Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks.
10) Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study.
11) Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study.
12) Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
20
1st name | |
Middle name | |
Last name | Naoyuki Kamatani |
Tsukuba International Clinical Pharmacology Clinic
Doctors' office
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
029-839-1150
kamatani@msb.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Masanori Suzuki |
Tsukuba International Clinical Pharmacology Clinic
Division for Volunteers
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
029-839-1150
m-suzuki@tsukuba-icp.jp
Tsukuba International Clinical Pharmacology Clinic
StaGen Co. Ltd.
Profit organization
NO
2017 | Year | 02 | Month | 26 | Day |
Partially published
https://www.jstage.jst.go.jp/article/gnam/41/2/41_171/_pdf/
Completed
2016 | Year | 08 | Month | 03 | Day |
2016 | Year | 08 | Month | 22 | Day |
2016 | Year | 09 | Month | 03 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 10 | Month | 10 | Day |
2017 | Year | 03 | Month | 30 | Day |
2016 | Year | 09 | Month | 13 | Day |
2017 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027667
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |