WHO ICTRP trial
An open label study in two parallel groups, each receiving in a randomized, two…
NL-OMON44101 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON44101 |
|---|---|
| Public title | An open label study in two parallel groups, each receiving in a randomized, two period, cross-over design two single doses of Risperdal® Consta®, to explore the comparative bioavailability of two different batches of Risperdal® Consta® and the intra subject variability of one Risperdal® Consta® batch after intramuscular administration in healthy volunteers |
| Scientific title | An open label study in two parallel groups, each receiving in a randomized, two period, cross-over design two single doses of Risperdal® Consta®, to explore the comparative bioavailability of two different batches of Risperdal® Consta® and the intra subject variability of one Risperdal® Consta®… |
| Primary sponsor | TEVA Pharma |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Countries | The Netherlands |
| Conditions | Schizophrenia;10039628;Schizophrenia |
| Interventions | The study will start with phase 1, an extended screening phase to determine subjects' tolerance to multiple oral doses of 1 mg risperidone (immediate release formulation) once daily for 3 days. During the screening phase standard medical… |
| Registration date | Jun 7, 2016 |
| Target size | 48 |
| Secondary IDs | 2015-004428-78;NL55433.056.15 |
| Registry page | onderzoekmetmensen.nl |
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: