NCT00829530已完成1 期
Randomized, 2-Way Crossover, Bioequivalence Study of Ramipril 10 mg Capsule and Altace® Administered as 1 x 10 mg Capsule in Healthy Subjects Under Fed 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
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed 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
- •Male or non-childbearing potential female, light smoker of non-smoker 18 years of age and older.
- •Capable of consent
- •Non-childbearing potential female subject is defined as follows:
- •Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration, or
- •Surgically sterile: hysterectomy, bilateral oophorectomy, or tubule ligation at least 6 months prior to drud administration.
排除标准
- •Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Any clinically significant abnormality found during medical screening.
- •Any reason which, in the opinion of the Medical Sub- Investigator, would prevent the subject from participating in the study.
- •Abnormal laboratory tests judged clinically significant, specifically BUN, serum creatinine and hyperkalemia.
- •Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- •EcG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) or change in the systolic blood pressure of 20 mmHg, or diastolic blood pressure of 10mmHg when passing from supine (after at least 5 minutes) to standing position ( after 1-3 minutes), at screening.
- •BMI ≥30.0kg/m
- •History of significant alcohol abuse within 6 months prior to the screening visit of any indication of the regular use of more than 14 units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL of 40% hard alcohol), or positive alcohol breath test at screening.
- •History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit of hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit of positive urine drug screen at screening.
- •History of allergic reactions to heparin, ramipril, or other ACE inhibitors, or other related drugs.
- •Use of any drugs known to induce hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoine, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- •Use of and investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- •Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver of kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of hte drug.
- •Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- •Use of prescription medication ( including hormone replacement therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Difficulty to swallow study medication.
- •Smoking more than 10 cigarettes per day.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- •A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- •Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- •50 mL to 300 mL of whole blood within 30 days,
- •301 mL to 500 mL of whole blood within 45 days, or
- •more than 500 mL of whole blood within 56 days prior to drug administration.
- •Intolerance to venipunctures
- •Clinically significant history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will nor be eligible for this study.
- •Unable to understand or unwilling to sign the Informed Consent Form.
- •Clinically significant history of angioedema.
- •History of known presence of volume-depletion (diuretics, dialysis, gastrointestinal disease) or hypotension.
- •History of collagen-vascular disease and/or renal disease.
- •History of ischemic heart disease, congestive heart failure, or cerebrovascular disease.
- •Breast-feeding subject.
- •Positive urine pregnancy test at screening.
研究组 & 干预措施
1
Experimental
干预措施: Ramipril 10 mg capsule (Drug)
2
Active Comparator
干预措施: Altace® 10 mg capsule (Drug)
结局指标
主要结局
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-t.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on Cmax.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-inf.
次要结局
- AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)for Ramiprilat.(Blood samples collected over a 72 hour period.)
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.(Blood samples collected over a 72 hour period.)
研究者
研究点 (1)
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