A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy
- Conditions
- Adult
- Registration Number
- JPRN-UMIN000027674
- Lead Sponsor
- Juntendo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Those who have hypersensitivity with phenylbutylate, its metabolites, drug additives and/or benzoate, etc. 2) Those who have experienced serious disease. 3) Those who have received medication in the previous two months. 4) Those who have received more than 200ml whole blood sampling in the previous 4 weeks, or blood component sampling in the previous 2 weeks. 5) Those who have received more than 400ml whole blood sampling in the previous 12 weeks. 6) Those who have been included in any phase 1 clinical trial for medicine containing new active ingredient in the previous 4 months. 7) Those who are less than 20 years old. 8) Drug addicts. 9) Alcoholics 10) Those who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine concentration of phenylbutylate and its metabolites in blood and urine after oral administration of sodium phenylbutyrate
- Secondary Outcome Measures
Name Time Method 1) Plasma amino acid fraction (isoleucine, glutamine, glutamic acid, argineine), and anmonia 2) Adverse events