Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet - Randomized, Open-label, Two-way Crossover Study to Establish the Bioequivalence Between BAY 77-1931 Orally Disintegrating Tablet 500 mg and Fosrenol Chewable Tablet 500 mg Administered in Japanese Healthy Male Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 20
- Primary Endpoint
- Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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)
Arms & Interventions
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.
Intervention: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) (Drug)
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.
Intervention: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) (Drug)
Outcomes
Primary Outcomes
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)