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Clinical trial

A Single Dose, Open-Label, Randomized, Four-Way Crossover, Fully Replicate, Bioequivalence Study of Generic Tacrolimus and Prograf® Capsules in Healthy Volunteers Under Fasting Conditions

NCT04725682 is registered in ClinicalTrials.gov with Food and Drug Administration (FDA) as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Single Dose, Open-Label, Randomized, Four-Way Crossover, Fully Replicate, Bioequivalence Study of Generic Tacrolimus and Prograf® Capsules in Healthy Volunteers Under Fasting Conditions
Lead sponsor
Food and Drug Administration (FDA)
Phase
Phase 1
Overall status
Completed
Start date
January 5, 2021
Completion date
June 17, 2021
Enrollment
67 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteers