Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Pharmacology

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03074058

18060

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Experimental group

Description:

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.

Treatment:

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

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Active Comparator group

Description:

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.

Treatment:

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