Conditions: Renal Transplant
Keywords: Renal transplant kidney transplant immunosuppressive therapy anti-rejection medication pharmacokinetics tacrolimus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 71
Healthy volunteers: no

Brief summary:
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.

Detailed description:

Arms:
arm 1: In Period 1 (Days 1-14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis). arm 2: In Period 1 (Days 1 - 14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15 - 28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).

Interventions: intervention 1: Generic Tacrolimus intervention 2: Branded Tacrolimus
Intervention descriptions: intervention 1: Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths. intervention 2: Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.

Protocol document: