WHO ICTRP trial
Darbepoetin Alfa
CTRI/2020/07/026718 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2020/07/026718 |
|---|---|
| Public title | Darbepoetin Alfa |
| Scientific title | A Phase I, single blind, randomized, controlled clinical study of the pharmacokinetics, pharmacodynamics, Tolerability and Safety of Multiple Intravenous Injections of Darbepoetin alfa, (manufactured by Hetero Biopharma Ltd., India.) and â??ARANESP®â?? (Darbepoetin alfa Injection, manufactured by… |
| Primary sponsor | PSK Pharma LLC |
| Secondary sponsors | Camus Pharma Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | India |
| Interventions | Intervention1: Darbepoetin (darbepoetin alfa) injection: for intravenous use, 1 μg/kg. Manufactured by Hetero Biopharma Ltd., India. Control Intervention1: Aranesp® (darbepoetin alfa) injection: for intravenous use, 1 μg/kg. Manufactured… |
| Registration date | Jul 21, 2020 |
| Target size | 62 |
| Secondary IDs | RBP/I/DPA-2/2019 Version No.: 1.0, Dated: 23/04/2019 |
| 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: