Trial Condition(s):

Clinical Pharmacology

Bioequivalence study of BAY 77-1931 orally disintegrating tablet

Bayer Identifier:

18060

ClinicalTrials.gov Identifier:

NCT03074058

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
20
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Fukuoka, Japan, 812-0025

Status
Completed
 

Trial Design