WHO ICTRP trial
Comparative assessment of the absorption of a generic formulation of 5/2.5 mg s…
ACTRN12620000327987 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting
Key facts
| Trial ID | ACTRN12620000327987 |
|---|---|
| Public title | Comparative assessment of the absorption of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet conducted under fasting conditions in healthy volunteers. |
| Scientific title | A single dose, randomized, open-label, pharmacokinetic study of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet in a 2 way crossover comparison against the innovator 5/2.5 mg s… |
| Primary sponsor | Zenith Technology Corporation Limited |
| Registry | Australian New Zealand Clinical Trials Registry (ANZCTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | New Zealand |
| Conditions | 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone belongs to a class of medicines called opioid analgesics and is prescribed for the relief of severe pain.; 5/2.5 mg s… |
| Interventions | Single dose, crossover study design whereby each participant receives the test formulation of 1 x 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet on one occasion and the innovator formulation… |
| Registration date | Sep 3, 2020 |
| Target size | 26 |
| 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: