WHO ICTRP trial
A clinical trial intended to compare Bioequivalence of two formulations of…
CTRI/2017/01/007744 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2017/01/007744 |
|---|---|
| Public title | A clinical trial intended to compare Bioequivalence of two formulations of Clozapine in patients with Schizophrenia or Schizoaffective Disorder. |
| Scientific title | A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Crossover, Multiple-Dose, Steady State, Bioequivalence Study of Clozapine Orally Disintegrating Tablets 100 mg of Cadila healthcare Ltd., India with Fazaclo® (Clozapine, USP) Orally Disintegrating Tablets 100mg Distributed by: Jazz… |
| Primary sponsor | Cadila Healthcare Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: null- Schizophrenia or Schizoaffective Disorder |
| Interventions | Intervention1: Clozapine: Clozapine (100 mg) will be administered administered in the morning and evening i.e. twice daily as per the randomization schedule daily from day 01 to day 10 in each period. Control Intervention1: Fazaclo® (Jazz… |
| Registration date | Jan 25, 2017 |
| Target size | 36 |
| Secondary IDs | CRL011611, Version 1.2 dated 04 Jan 2017 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: