Normal adult males
Conditions
Interventions
SG-1 (20 mg compound A and 0.5 g compound B) is administered to 1 subject twice a day for 14 days
20 mg compound A is administered to 3 subjects twice a day for 14 days
0.5 g compound B is administere
Sponsors
Tsukuba International Clinical Pharmacology Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of blood and urine purine compounds at 14 days after the daily administration of drugs | — |
Countries
Japan
Contacts
Public ContactMasanori Suzuki
Tsukuba International Clinical Pharmacology Clinic Division for Volunteers
Outcome results
None listed