An Open-label, Randomized, Single-dose, 3-period, 3-treatment Crossover Study to Assess the Comparative Bioavailability of 5mg Cinacalcet Capsules to the 30mg Commercial Formulation Cinacalcet Tablets in Healthy Adult Volunteers

Amgen, Inc.0 个研究点目标入组 42 人开始时间: 2014年11月13日最近更新: 2014年11月17日

适应症

试验速览

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•- Healthy men and women 18 to 45 years of age, inclusive at the time of randomization.
•- Clinically acceptable physical examination (including blood pressure and heart rate measurements), laboratory tests (blood hematology, blood chemistries and urinalysis), ECG (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals) and no history of evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.
•- A body mass index between 18-32 kg/m2, inclusive at the time of screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
•- Clinically significant abnormality in clinical chemistry, hematology or urinalysis parameters, as determined by the investigator and Amgen.
•- History of epilepsy or seizure disorder.
•- History of cardiac arrhythmia.
•- Serum calcium < 9.0 mg/dL at screening or Day-1.
•- Known allergies to cinacalcet or its excipients.

发起方