Clinical Pharmacology
Conditions
Brief summary
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.
Interventions
DRUGFosrenol ODT (Lanthanum Carbonate, BAY77-1931)
Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
DRUGFosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.g. weak biting force, insufficient salivary flow)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day | 6 days | 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. |
| Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period | baseline and over 3-days | During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3 | 1 day | — |
| 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 | — |
| 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 | — |
| Plasma lanthanum concentrations (ng/mL) | 6 days | 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. |
Countries
Japan
Outcome results
None listed