NCT00865215已完成1 期
A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
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
- Actavis Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
The purpose of this study is TO compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions.
详细描述
Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions
Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers who have been informed of the nature of the study and agree to read, review and sign the informed consent document prior to Period I dosing.
- •Volunteers who have completed the screening process within 28 days prior to Period I dosing.
- •Volunteers who are healthy adult men and women 18 to 50 years of age, inclusive, at the time of dosing.
- •Volunteers who have a body mass index (BMI) between 18-32 kg/m2, inclusive, and weigh at least 110 lbs.
- •Volunteers who are healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
- •Volunteers who have a negative urine drug screen.
- •Female volunteers must have a negative pregnancy screen.
- •Female volunteers practicing an acceptable method of birth control as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence throughout the duration of the study; or of postmenopausal (no menses) status for at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
排除标准
- •Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- •Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- •Volunteers whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- •Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- •Volunteers who report a history of allergic response(s) to propranolol or related drugs.
- •Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing.
- •Volunteers who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- •Volunteers who report a history of clinically significant allergies including drug allergies.
- •Volunteers who report a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- •Volunteers who report a history of drug or alcohol addiction or abuse within the past year.
- •Volunteers who demonstrate a positive drug abuse screen for this study prior to Period I dose administration.
- •Volunteers who currently use tobacco products.
- •Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- •Volunteers who report donating plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- •Volunteers who demonstrate a positive pregnancy screen (females only).
- •Volunteers who are currently pregnant or breastfeeding (females only).
研究组 & 干预措施
A
Experimental
Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose
干预措施: Propranolol Hydrochloride Extended Release Capsules 160 mg (Drug)
B
Active Comparator
INDERAL® LA 160 mg Capsules, single dose
干预措施: INDERAL® LA 160 mg Capsules, single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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