WHO ICTRP trial
Study of Cariprazine Capsules 6 mg in Schizophrenia or Bipolar disorder I…
CTRI/2019/04/018793 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2019/04/018793 |
|---|---|
| Public title | Study of Cariprazine Capsules 6 mg in Schizophrenia or Bipolar disorder I patients who are receiving Cariprazine capsules 6 mg as stable dose |
| Scientific title | A Multicentric, Open-label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Multiple dose, Steady state Clinical Bioequivalence Study of Cariprazine Capsules 6 mg of Aurobindo Pharma Limited, India (Test) with VRAYLAR (Cariprazine) Capsules 6 mg of Allergan USA, Inc. Irvine, CA… |
| Primary sponsor | Aurobindo Pharma Limited |
| Secondary sponsors | AXIS Clinicals Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: F208- Other schizophrenia |
| Interventions | Intervention1: Cariprazine Capsules 6 mg: Patients will be administered one capsule of Test or Reference once daily per orally from day 1 to day 14 in period-I and from day 15 to day 28 in period-II Control Intervention1: VRAYLAR… |
| Registration date | Apr 25, 2019 |
| Target size | 40 |
| Secondary IDs | CR193-18 Version 1.0 Dated 04.07.2018 |
| 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: