WHO ICTRP trial
Bioequivalence study of Betahistine Dihydrochloride Orally disintegrating strips
CTRI/2019/05/019483 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2019/05/019483 |
|---|---|
| Public title | Bioequivalence study of Betahistine Dihydrochloride Orally disintegrating strips |
| Scientific title | A Randomized,Open label, Balanced, Two Treatment, Two period, Two sequence, Single Dose,Crossover, Bioequivalence study of BetahistineDihydrochloride Orally disintegrating strip (ODS) 24 mg of Shilpa Therapeutics Pvt. Ltd (Co-developed by Abbott India Ltd.) with Vertin (Betahistine) 24 mg Tablets of… |
| Primary sponsor | Shilpa Therapeutics Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Phase | Phase 1 |
| Countries | India |
| Interventions | Intervention1: BetahistineDihydrochloride Orally disintegrating strip (ODS) 24 mg: In each Period, single test IMP (24 mg ODS) will be placed on subjects tongue and will be allowed to disintegrate, swallowed the saliva and followed by 240… |
| Registration date | May 31, 2019 |
| Target size | 36 |
| Secondary IDs | ARL/17/529 Version 2.0; 03-05-2019 Study Code: BETA1010 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: