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Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
Sponsor: Chong Kun Dang Pharmaceutical
Summary
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
Official title: Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2017-11-30
Completion Date
2020-09-29
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
tacrolimus tablet
* Orally, twice a day in the morning and night * After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7\~12ng/ml for 0 to 3months and then at 5\~8ng/ml for 3 to 6months of study treatment.
tacrolimus capsules
* Orally, twice a day in the morning and night * After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7\~12ng/ml for 0 to 3months and then at 5\~8ng/ml for 3 to 6months of study treatment.
Locations (1)
Seoul National University Hospital
Seoul, South Korea