WHO ICTRP trial
Comparative assessment of the absorption of a generic formulation of clobazam…
ACTRN12616001418460 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting
Key facts
| Trial ID | ACTRN12616001418460 |
|---|---|
| Public title | Comparative assessment of the absorption of a generic formulation of clobazam suspension against the innovator clobazam suspension conducted under fed conditions in healthy male and female volunteers |
| Scientific title | A single dose, randomized, blinded, bioequivalence study of a test formulation of clobazam suspension in a 2 way crossover comparison against the innovator clobazam suspension conducted under fed conditions in healthy male and female volunteers |
| Primary sponsor | Zenith Technology Corp Ltd |
| Registry | Australian New Zealand Clinical Trials Registry (ANZCTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | New Zealand |
| Conditions | Bioequivalence study conducted in healthy volunteers comparing two formulations of clobazam with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the… |
| Interventions | Single dose, crossover study design whereby each participant receives the test formulation of clobazam (1 x 20 mg of 2.5 mg/mL) on one occasion and the innovator formulation of clobazam (1 x 20 mg of 2.5 mg/mL) on one occasion with each… |
| Registration date | Nov 10, 2016 |
| Target size | 30 |
| Registry page | anzctr.org.au |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: