Approval Probability
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ML Risk
Fosrenol ODT · 1 trial · 1 indication
Each study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.
During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)
| Arm | Type | Description |
|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) | EXPERIMENTAL | Fosrenol BAY 77-1931 orally disintegrating tablet (ODT) 500 mg in Period 1 (day 1-3) and Fosrenol chewable tablet 500mg in Period 2 (day 4-6). The washout interval between period 1 and 2 will be at least 14 days. |
| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) | ACTIVE_COMPARATOR | Fosrenol BAY77-1931 chewable tablet in Period 1 and Fosrenol BAY 77-1931 ODT 500 mg in Period 2. The washout interval between period 1 and 2 will be at least 14 days. |
| Name | Type | Description |
|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) | DRUG | Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID |
| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) | DRUG | Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID |
Inclusion Criteria: * Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2) Exclusion Criteria: * Regular use of medicines including Chinese herbal drugs * Clinically relevant findings in the physical examination * Subject who cannot take the study drug appropriately (e....
Fosrenol ODT is an orally disintegrating tablet formulation developed by Bayer AG under the code BAY77-1931. It is a small molecule studied in clinical pharmacology, specifically in a bioequivalence trial comparing the orally disintegrating tablet against another formulation. It is also known as lanthanum carbonate.
Fosrenol ODT was studied in the clinical pharmacology setting, with its single trial conducted in healthy adult male volunteers rather than in patients with a disease indication. The trial evaluated bioequivalence of the orally disintegrating tablet formulation. No patient-facing indication is described for this specific development program.
Fosrenol ODT is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the bioequivalence study of the orally disintegrating tablet formulation, which was conducted in Japan.
Fosrenol ODT is in Phase 1 development. Its only recorded trial, NCT03074058, was a Phase 1 bioequivalence study that has been completed. The program has no active trials, and the available information does not indicate that this orally disintegrating tablet formulation is approved.
Fosrenol ODT has been studied in one completed Phase 1 trial, NCT03074058, titled Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet. The trial enrolled 20 healthy male volunteers aged 20 years and older in Japan, was randomized, and used an active control design.
Yes, Fosrenol ODT is also known as lanthanum carbonate and by the development code BAY77-1931. The orally disintegrating tablet is a formulation of lanthanum carbonate, and the bioequivalence study NCT03074058 was designed to compare this orally disintegrating tablet against another formulation of the same compound.