Trials / Unknown
UnknownNCT02808065
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.
Detailed description
Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus | Administered dose were individualized according to their own prescription |
| DRUG | Mycophenolate mofetil | Administered dose were individualized according to their own prescription |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2016-06-21
- Last updated
- 2016-06-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02808065. Inclusion in this directory is not an endorsement.