NCT04014062View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

February 12, 2018

Primary Completion Date

May 1, 2018

Study Completion Date

May 1, 2018

Conditions
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Interventions
COMBINATION_PRODUCT

INTP5

INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.

COMBINATION_PRODUCT

US Neulasta

US Neulasta: FDA-approved pegfilgrastim innovator product.

Trial Locations (1)

Ahmedabad-382481

Lambda Therapeutic Research Ltd., Ahmedabad

Sponsors
All Listed Sponsors
collaborator

Lambda Therapeutic Research Ltd.

INDUSTRY

lead

Intas Pharmaceuticals, Ltd.

INDUSTRY