NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031190115

Registered date:11/10/2019

PK & PD of coadministration of XOR inhibitor and inosine

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment11/10/2019
Target sample size28
Countries of recruitment
Study typeInterventional
Intervention(s)Coadministration of allopurinol and inosine, or coadministration of febuxostat and inosine

Outcome(s)

Primary OutcomeConcentration of hypoxanthine in blood
Secondary Outcome1. Cmax and AUC for febuxostat, allopurinol and oxypurinol 2. Serum urate 3. Blood ATP concentration 4. Concentration of xanthine in blood

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 40age old
GenderMale
Include criteria1) Japanese healthy adult male 2) A person who voluntarily applied to the study and is determined by the principal investigator or subinvestigators to understand the contents of the explanatory document. 3) A person who has received sufficient explanation about the purpose and content of this study, has the ability to consent, fully understands and agrees to participate by writing, in a voluntary manner, in the document. 4) Age 20 to 40 (age is on the date of consent) 5) Person with a BMI of 17.6 or more and less than 26.5 (BMI is at the time of screening test).
Exclude criteria1) Regular users of pharmaceuticals or supplements 2) Persons who are being treated for disease 3) Persons with renal impairment or past history of the renal impairment 4) History of gout, hyperuricemia or urolithiasis 5) History or present illness of renal disorder 6) History or present illness of cardiovascular disorder 7) Persons with hypersensitivity to drugs, idiosyncrasies (allergies), or past history of those 8) Those who have a disease or disorder in the heart, kidney, respiratory system, digestive system, blood function, etc. that may affect the absorption, distribution, metabolism, or excretion of the drug 9) Those who have participated in other clinical trials such as clinical trials of drugs containing new active ingredients within the past 4 weeks from the start date of test drug administration 10) Those who donated 400mL blood within the past 12 weeks, 200mL blood within 4 weeks, or blood component within 2 weeks from the screening test date 11) Other persons who are judged to be ineligible by the principal investigator or subinvestigator

Related Information

Contact

Public contact
Name Masa-aki Mochii
Address 21-16, Kan-nondai 1-chome, Tsukuba-shi, Ibaraki, Japan Ibaraki Japan 305-0856
Telephone +81-29-839-1150
E-mail m-mochii@tsukuba-icp.jp
Affiliation Tsukuba International Clinical Pharmacology Clinic
Scientific contact
Name Naoyuki Kamatani
Address 21-16, Kan-nondai 1-chome, Tsukuba-shi, Ibaraki, Japan Ibaraki Japan 305-0856
Telephone +81-29-839-1150
E-mail kamatani@msb.biglobe.ne.jp
Affiliation Tsukuba International Clinical Pharmacology Clinic