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临床试验/NCT01053676
NCT01053676已完成1 期

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

Bayer0 个研究点目标入组 59 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Bayer
入组人数
59
主要终点
Bioequivalence based on daily urinary phosphate excretion

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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/m
  • Volunteers who are judged by the investigators to be suitable for enrollment in this clinical trial based upon the data from a screening test.

排除标准

  • 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

研究组 & 干预措施

Arm 1

Experimental

干预措施: Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule (Drug)

Arm 2

Active Comparator

干预措施: Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet (Drug)

结局指标

主要结局

Bioequivalence based on daily urinary phosphate excretion

时间窗: Follow up examination cunducted on 7 to 10 days after the last drug administration

次要结局

  • Adverse event collection(Follow up examination cunducted on 7 to 10 days after the last drug administration)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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