NCT04014062

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.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Intas Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; INTP5 and US-Neulasta) in healthy, adult, human subjects under fed conditions.

Conditions

• Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	INTP5	INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.
COMBINATION_PRODUCT	US Neulasta	US Neulasta: FDA-approved pegfilgrastim innovator product.

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2019-07-10
• Last updated: 2019-10-04
• Results posted: 2019-10-04

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study