Healthy Volunteers
Conditions
Keywords
Healthy volunteer
Brief summary
Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction between two drugs is still not well understood. Therefore, an open-label, three period, single dose trial is planned to investigate the drug interaction between tacrolimus and mycophenolate mofetil.
Detailed description
Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg. All subjects have one week of washing period between single dose administration. Blood samples are drawn up to 72 hours after drug administration. Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated. Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.
Interventions
DRUGTacrolimus
DRUGMycophenolate mofetil
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male adult with age of 19-45 * Weight difference between ideal and actual body weight is less than 20% * Previous healthy with no known disease * Considered normal on physical exam, clinical laboratory tests(complete blood count, electrolyte, renal and hepatic function) and electrocardiogram * Never been heavy-drinker within one month prior to trial initiation and able to abstain from alcohol during trial
Exclusion criteria
* Ever smoked within one year prior to trial initiation * Took other drugs (including herbal medicine) within one month prior to trial initiation * Alcohol or drug abuser * Participated another clinical trial within three months * Considered inadequate under investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil | 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Peak Concentration of Tacrolimus and Mycophenolate mofetil | 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose |
| Adverse Drug Reaction | through study completion, an average of 1 month |
Countries
South Korea
Outcome results
None listed