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Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

NCT03074058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-10
Primary Completion
2015-08-04
Completion
2015-08-21

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074058 on ClinicalTrials.gov