Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
- Conditions
- Clinical Pharmacology
- Interventions
- Registration Number
- NCT03074058
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 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. Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3 1 day Pharmacokinetics: tmax,md of lanthanum in plasma from 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: t1/2,md of lanthanum in plasmafrom 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.
Pharmacokinetics: Cmax,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