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Bioequivalence Study of BAY77-1931 Granule

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule
Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia, BE, Granule, Healthy volunteers

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Japanese male volunteers who must have given their written informed consent to participate in the study
  • Age is between 20 and 45 years
  • Body Mass Index (BMI) is between 17.6 and 26.4 kg/m2.
  • Volunteers who are judged by the investigators to be suitable for enrollment in this clinical trial based upon the data from a screening test.

Exclusion Criteria:

  • A history of relevant diseases of internal organs (diseases that may significantly jeopardize body systems, such as severe liver or renal dysfunction, active peptic ulcer, ulcerative colitis, Crohn's disease, narrowing of colon lumen) or, of the central nervous system (e.g., epilepsy), or other organs which are likely to show inappropriateness for participation in this study
  • Conditions of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator (mental diseases that are thought to be ineligible for the communal life in the study participation, unable to consent to the participation, disables)
  • Known drug hypersensitivity or idiosyncrasy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Bioequivalence based on daily urinary phosphate excretion

Secondary Outcome Measures

Adverse event collection

Full Information

First Posted
January 20, 2010
Last Updated
June 20, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01053676
Brief Title
Bioequivalence Study of BAY77-1931 Granule
Official Title
Bioequivalence Study of BAY77-1931 Granule - Randomized, Non-blind, Two-way, Crossover Study to Establish the Bioequivalence Between BAY77-1931 Granule 500 mg and Fosrenol Chewable Tablet 500 mg in Japanese Healthy Male Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first drug administration of period 1 (before the hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about 1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should consume at least 95% of a meal. Distilled water not to include phosphate will be used for drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in clinic to make sure enough urine volume. The 24 hours urine collection will be conducted between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule 500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study drugs will be administered immediately after each meal, that is within 20 minutes after start of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken after chewing completely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
Hyperphosphatemia, BE, Granule, Healthy volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule
Intervention Description
BAY77-1931 Granule TID for 4 days
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
Intervention Description
BAY77-1931 Chewable tablet TID for 4 days
Primary Outcome Measure Information:
Title
Bioequivalence based on daily urinary phosphate excretion
Time Frame
Follow up examination cunducted on 7 to 10 days after the last drug administration
Secondary Outcome Measure Information:
Title
Adverse event collection
Time Frame
Follow up examination cunducted on 7 to 10 days after the last drug administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Japanese male volunteers who must have given their written informed consent to participate in the study Age is between 20 and 45 years Body Mass Index (BMI) is between 17.6 and 26.4 kg/m2. Volunteers who are judged by the investigators to be suitable for enrollment in this clinical trial based upon the data from a screening test. Exclusion Criteria: A history of relevant diseases of internal organs (diseases that may significantly jeopardize body systems, such as severe liver or renal dysfunction, active peptic ulcer, ulcerative colitis, Crohn's disease, narrowing of colon lumen) or, of the central nervous system (e.g., epilepsy), or other organs which are likely to show inappropriateness for participation in this study Conditions of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator (mental diseases that are thought to be ineligible for the communal life in the study participation, unable to consent to the participation, disables) Known drug hypersensitivity or idiosyncrasy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan

12. IPD Sharing Statement

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Bioequivalence Study of BAY77-1931 Granule

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