A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration - Pravastatin in Plasma
研究概览
简要总结
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.
详细描述
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking male and female subjects, 18 years of age or older.
- •BMI greater than or equal to 19 and less than or equal to
- •Negative for:
- •Hepatitis B surface antigen and Hepatitis C antibody.
- •Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- •Urine cotinine test
- •Serum HCG consistent with pregnancy (females only)
- •No significant diseases or clinically significant findings in a physical examination.
- •No clinically significant abnormal laboratory values.
- •No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
- •Be informed of the nature of the study and given written consent prior to receiving any study procedure.
- •Females who participate in this study are:
- •unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy or,
- •willing to remain abstinent [not engage in sexual intercourse] or,
- •willing to use an effective method of double-barrier birth control [partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD].
- •Females who participate in this study are non-lactating.
排除标准
- •Known history or presence of any clinically significant medical condition.
- •Known or suspected carcinoma.
- •Known history or presence of:
- •Hypersensitivity or idiosyncratic reaction to pravastatin sodium and/or any other drug substances with similar activity.
- •Alcoholism within the last 12 months.
- •Drug dependence and/or substance abuse.
- •Use of tobacco or nicotine-containing products within the last 6 months.
- •On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
- •Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
- •Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
- •Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- •Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- •Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
- •Difficulty fasting or consuming the standard meals.
- •Do not tolerate venipuncture.
- •Unable to read or sign the ICF.
研究组 & 干预措施
Pravastatin
Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
干预措施: Pravastatin sodium 80 mg tablets (Drug)
Pravachol®
Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
干预措施: Pravachol® 80 mg tablets (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration - Pravastatin in Plasma
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-t
次要结局
未报告次要终点