Bioequivalence Study of BAY77-1931 Granule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01053676
First received: January 20, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hyperphosphatemia
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bioequivalence based on daily urinary phosphate excretion [ Time Frame: Follow up examination cunducted on 7 to 10 days after the last drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: Follow up examination cunducted on 7 to 10 days after the last drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule
BAY77-1931 Granule TID for 4 days
Active Comparator: Arm 2 Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
BAY77-1931 Chewable tablet TID for 4 days

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053676

Locations
Japan
Osaka, Japan, 532-0003
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01053676     History of Changes
Other Study ID Numbers: 13287
Study First Received: January 20, 2010
Last Updated: June 20, 2014
Health Authority: Japan: Pharmaceutical Medical Devises Agency

Keywords provided by Bayer:
Hyperphosphatemia
BE
Granule
Healthy volunteers

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014