WHO ICTRP trial
A STUDY OF FILGRASTIM INJECTIONS IN HUMANS
CTRI/2021/03/031763 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/03/031763 |
|---|---|
| Public title | A STUDY OF FILGRASTIM INJECTIONS IN HUMANS |
| Scientific title | A RANDOMIZED, ASSESSOR-BLIND, MULTIPLE-DOSE, TWO-TREATMENT, TWO-PERIOD, TWO-WAY CROSSOVER STUDY COMPARING THE PHARMACODYNAMICS OF INTP1 FROM INTAS PHARMACEUTICALS LTD., INDIA AND NEUPOGEN® OF AMGEN INC., USA FOLLOWING SUBCUTANEOUS INJECTIONS IN HEALTHY, ADULT HUMAN SUBJECTS |
| Primary sponsor | Intas Pharmaceuticals Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | India |
| Interventions | Intervention1: INTP1; Active content: Filgrastim: Dose for administration: 5 mcg/kg; Manufacturer: Intas Pharmaceuticals Ltd., India; Pharmaceutical form: Pre-filled syringe; Route of administration: Subcutaneous Control Intervention1… |
| Registration date | Aug 3, 2021 |
| Target size | 60 |
| Secondary IDs | 0365-19, Version 1.1, Dated 11 Aug 2020 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: