WHO ICTRP trial
Study to prove bioequivalence of Risperidone prolonged-release susp. for Intra…
CTRI/2018/01/011521 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2018/01/011521 |
|---|---|
| Public title | Study to prove bioequivalence of Risperidone prolonged-release susp. for Intra Muscular inj 25 mg/vial of Pharmathen S.A. Greece in adult schizophrenic patients who are on stable dose. |
| Scientific title | A randomized, multi center, open label, balanced, two-treatment, two-period, two-sequence, multiple dose, crossover, steady-state bioequivalence study of Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece in comparison with RISPERDAL CONSTA 25… |
| Primary sponsor | Pharmathen S A |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: null- Schizophrenia |
| Interventions | Intervention1: Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece.: patient will receive his/her established maintenance dose of Risperidone 25 mg/vial prolonged-release suspension for… |
| Registration date | Jan 23, 2018 |
| Target size | 100 |
| Secondary IDs | 17-VIN-0317 |
| 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: