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Clinical trial

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

NCT03375138 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants
Lead sponsor
Bristol-Myers Squibb
Phase
Phase 1
Overall status
Completed
Start date
December 4, 2017
Completion date
April 2, 2019
Enrollment
84 (actual)
Sites
2

Conditions

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

healthy volunteers