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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.

NCT04014062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-10-04

Study results available
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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

COMBINATION_PRODUCT

INTP5

INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.

COMBINATION_PRODUCT

US Neulasta

US Neulasta: FDA-approved pegfilgrastim innovator product.

Sponsors & Collaborators

  • Lambda Therapeutic Research Ltd.

    collaborator INDUSTRY

  • Intas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Anshul Attrey, M.D. · Lambda Therapeutic Research Ltd.

  • Vinu Jose, M.D. · Intas Pharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-05-01
Completion
2018-05-01
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014062 on ClinicalTrials.gov