# 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** · PHASE1 · COMPLETED · sponsor: **Intas Pharmaceuticals, Ltd.** · enrollment: 144 (actual)

## Conditions studied

- Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers

## Interventions

- **COMBINATION_PRODUCT:** INTP5
- **COMBINATION_PRODUCT:** US Neulasta

## Key facts

- **NCT ID:** NCT04014062
- **Lead sponsor:** Intas Pharmaceuticals, Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-02-12
- **Primary completion:** 2018-05-01
- **Final completion:** 2018-05-01
- **Target enrollment:** 144 (ACTUAL)
- **Last updated:** 2019-10-04

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04014062

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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.". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04014062. Licensed CC0.

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