Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03074058
• Date of registration: 03/03/2017
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
• Scientific title: 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
• Date of first enrolment: June 10, 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03074058
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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)



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Clinical Pharmacology

Intervention(s)

Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Primary Outcome(s)

Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day [Time Frame: 6 days]

Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period [Time Frame: baseline and over 3-days]

Secondary Outcome(s)

Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Number of adverse events as a measure of safety and tolarability [Time Frame: 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: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Plasma lanthanum concentrations (ng/mL) [Time Frame: 6 days]

Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3 [Time Frame: 1 day]

Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6) [Time Frame: 6 days]

Secondary ID(s)

18060

Source(s) of Monetary Support

Please refer to primary and secondary sponsors