NCT03074058

Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clinical Pharmacology

Interventions

Type	Name	Description
DRUG	Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)	Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
DRUG	Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)	Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID

Timeline

• Start date: 2015-06-10
• Primary completion: 2015-08-04
• Completion: 2015-08-21
• First posted: 2017-03-08
• Last updated: 2017-03-21

Locations

1 site across 1 country: Japan