WHO ICTRP trial
Phase-I clinical trial of Stelis Insulin Glargine injection 100IU/mL in healthy…
CTRI/2020/12/030079 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2020/12/030079 |
|---|---|
| Public title | Phase-I clinical trial of Stelis Insulin Glargine injection 100IU/mL in healthy adults |
| Scientific title | A double-blind, randomized, single-center, two treatment, four period, two sequence, replicate crossover, euglycemic clamp study to demonstrate equivalence in the Pharmacokinetic and Pharmacodynamic properties of Insulin Glargine injection 100IU/mL of Stelis Biopharma and LANTUS® (Insulin Glargine… |
| Primary sponsor | Stelis Biopharma Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | India |
| Interventions | Intervention1: Stelis Insulin Glargine: Single dose of 0.4 IU/kg of Stelis Insulin Glargine 100 IU/mL, will be administered as per the randomization schedule via subcutaneous route at each period under fasting condition Control… |
| Registration date | Dec 28, 2020 |
| Target size | 48 |
| Secondary IDs | 19-VIN-0348, Version 1.0, amendment- 001, dated 28 Feb 2020 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: