- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053676
Bioequivalence Study of BAY77-1931 Granule
June 20, 2014 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Osaka, Japan, 532-0003
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 2
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BAY77-1931 Chewable tablet TID for 4 days
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Experimental: Arm 1
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BAY77-1931 Granule TID for 4 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on daily urinary phosphate excretion
Time Frame: Follow up examination cunducted on 7 to 10 days after the last drug administration
|
Follow up examination cunducted on 7 to 10 days after the last drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event collection
Time Frame: Follow up examination cunducted on 7 to 10 days after the last drug administration
|
Follow up examination cunducted on 7 to 10 days after the last drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (Estimate)
January 21, 2010
Study Record Updates
Last Update Posted (Estimate)
June 23, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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