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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 of a small molecule drug being developed by Bayer AG. It is currently in Phase 1 clinical development for clinical pharmacology studies. The drug is being investigated in healthy volunteers to assess its bioequivalence and pharmacokinetic profile.
Fosrenol ODT is being studied for clinical pharmacology purposes, specifically to evaluate the bioequivalence of the orally disintegrating tablet formulation. The ongoing research focuses on understanding how the drug is absorbed and processed in the body, which is essential for its potential future therapeutic applications.
Fosrenol ODT is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the drug's bioequivalence and pharmacological properties.
Fosrenol ODT is currently in Phase 1 clinical development. The drug is in the early stages of clinical testing, with one completed Phase 1 trial involving 20 healthy male volunteers in Japan. It is still investigational and has not yet been approved by regulatory authorities.
Fosrenol ODT has one completed clinical trial registered under NCT03074058, titled "Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet." This Phase 1 study enrolled 20 healthy male volunteers in Japan and was active-controlled, though not double-blinded. The trial has been completed.
Yes, Fosrenol ODT is also known as BAY 77-1931. The clinical trial NCT03074058 refers to the drug as BAY 77-1931 orally disintegrating tablet, confirming that these names refer to the same drug product being developed by Bayer AG.