Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2015-08-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinical Pharmacology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

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.

Group Type EXPERIMENTAL

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Intervention Type DRUG

Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

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.

Group Type ACTIVE_COMPARATOR

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Intervention Type DRUG

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID

Interventions

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Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID

Intervention Type DRUG

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes