EUCTR2012-000706-30-Outside-EU/EEA进行中（未招募）不适用
An Open Label, Randomized, Single Dose, Two-Way Crossover bioequivalence Study Comparing a New 80 mg (2x40 mg) Pediatric Appropriate Formulation to an 80 mg Commercial Atorvastatin Calcium Tablet Formulation in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Healthy male and/or female subjects between the ages of 18 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
排除标准
- •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 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 smoke 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 or 5 half-lives (whichever was longer) prior to the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing intra-uterine device [IUDs], postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol could be
- •used at doses of =1 g/day. Limited use of non-prescription medications that were not believed to affect subject safety or the overall results of the study could be permitted on a case-by-case basis following approval by the sponsor.
- •10. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- •11. History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •12. Unwilling or unable to comply with the Lifestyle guidelines described in the protocol.
- •13. Consumption of grapefruit or grapefruit-containing products within 7 days prior to the
- •first dose of study medication.
- •14. Subjects with serum creatine kinase levels >3x upper limit of normal.
- •15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may have increased the risk associated with study participation or investigational product administration or may have interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry
- •into this study.
- •16. Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to atorvastatin or other statins.
研究者
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