WHO ICTRP trial
Comparative assessment of the absorption of a generic formulation of ferrous…
ACTRN12618000222246 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting
Key facts
| Trial ID | ACTRN12618000222246 |
|---|---|
| Public title | Comparative assessment of the absorption of a generic formulation of ferrous sulfate/sodium ascorbate modified release tablet against the innovator ferrous sulfate/sodium ascorbate modified release tablet conducted under fasting conditions with diet control in healthy male volunteers |
| Scientific title | A single dose, randomized, blinded, bioequivalence study of a test formulation of ferrous sulfate/sodium ascorbate controlled release tablet in a 2 way crossover comparison against the innovator ferrous sulfate/sodium ascorbate modified release tablet conducted under fasting conditions with diet… |
| 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 | Iron deficiency. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, ferrous sulfate and vitamin C is an iron supplement indicated for the prevention and… |
| Interventions | Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate/sodium ascorbate (1 x 325mg /562.4 mg) on one occasion and the innovator formulation of ferrous sulfate/sodium ascorbate (1 x… |
| Registration date | Dec 2, 2018 |
| 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: