WHO ICTRP trial
Comparative assessment of the absorption of a generic formulation of…
ACTRN12619001338156 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting
Key facts
| Trial ID | ACTRN12619001338156 |
|---|---|
| Public title | Comparative assessment of the absorption of a generic formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule against the innovator 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule conducted under fasting conditions in healthy male volunteers. |
| Scientific title | A single dose, randomized, blinded, pharmacokinetic study of a test formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule in a 2 way crossover comparison against the innovator 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule conducted under fasting… |
| 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 | 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation… |
| Interventions | Single dose, crossover study design whereby each participant receives the test formulation of 4 mg 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule on one occasion and the innovator formulation 4 mg… |
| Registration date | Sep 30, 2019 |
| Target size | 24 |
| 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: