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Clinical trial

An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.

NCT04014062 is registered in ClinicalTrials.gov with Intas Pharmaceuticals, Ltd. as lead sponsor.

NCT NCT04014062
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Registry record

As filed in ClinicalTrials.gov.

Title
An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.
Lead sponsor
Intas Pharmaceuticals, Ltd.
Phase
Phase 1
Overall status
Completed
Start date
February 12, 2018
Completion date
May 1, 2018
Enrollment
144 (actual)
Sites
1

Conditions

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

pharmacokinetic bioequivalence study in human healthy volunteers