CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 144 enrolled
Drug / intervention
INTP5 +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04014062
NCT04014062Phase 1Completed
CompareCT.gov

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.

Intas Pharmaceuticals, Ltd.·interventional·Posted Jul 10, 2019·Updated Oct 4, 2019

In Brief

A Phase 1 clinical trial evaluating INTP5 and US Neulasta for Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetic Bioequivalence Study in Human Healthy Volunteers
CountriesIndia
CollaboratorsLambda Therapeutic Research Ltd.

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartFeb 12, 2018
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.0 years ago

Interventions

INTP5combination

INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.

US Neulastacombination

US Neulasta: FDA-approved pegfilgrastim innovator product.