An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing a Pediatric Appropriate Formulation to a 10 mg Commercial Atorvastatin Calcium Tablet Formulation in Healthy Subjects - BE Study Comparing a Pediatric Formulation to a 10 mg Commercial Atorvastatin Calcium Tablet Formula

Pfizer Inc0 个研究点目标入组 76 人开始时间: 2012年2月13日最近更新: 2012年3月20日

试验速览

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•1. Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (healthy was defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure [BP] and pulse rate measurement, 12-lead electrocardiogram [ECG], and clinical laboratory tests).
•2. Body mass index (BMI) of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs). A BMI lower limit of 17.5 kg/m2 was permitted to be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 was permitted to be rounded down to 30.0 kg/m2 and was acceptable for inclusion.
•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 76
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.
•2. Any condition possibly affecting drug absorption (eg, gastrectomy).
•3. A positive urine drug screen.
•4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of hard liquor) within 6 months of Screening.
•5. Subjects who smoked more than 5 cigarettes per day.
•6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
•7. 12-lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeded 450 msec, the ECG was to be repeated two more times and the average of the three QTc values was to be used to determine the subject’s eligibility.
•8. Pregnant or nursing females; females of childbearing potential who were unwilling or unable to use an acceptable method of non-hormonal contraception from at least 14 days prior to the first dose of study medication.
•9. Use of prescription or nonprescription drugs and dietary supplements within 7 days

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