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The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) | Drug | Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day | 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. | 6 days |
| Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period | During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6) | baseline and over 3-days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3 | 1 day | |
| Plasma lanthanum concentrations (ng/mL) | To measure plasma concentration of lanthanum, 6 mL of blood were collected before the breakfast on Day 1, Day 2, Day 3 and Day 4, and at 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours after administration on Day 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Fukuoka | 812-0025 | Japan |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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| Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) | Drug | Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID |
|
| 6 days |
| Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |
| Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |
| Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |
| Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |
| Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |
| Number of adverse events as a measure of safety and tolarability | From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6) |
| Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) | 6 days |