Pharmacokinetics Clinical Trial
Official title:
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
Verified date | May 2015 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.
Status | Completed |
Enrollment | 80 |
Est. completion date | |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: - ABO-compatible renal transplant recipients Exclusion Criteria: - multi-organ transplant - HIV(+) donor or recipients - history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca) - more than three-fold increase in AST or ALT level for 28 days - pregnancy - lactation |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetics | at postoperative 10~14 days and at postoperative 6 months for crossover study |
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