A Single-Dose, Comparative Bioavailability Study of Two Formulations of Trandolapril 4 mg Tablets Under Fed Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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 HIV, Hepatitis B surface antigen and Hepatitis C antibody, urine 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 the 12-lead electrocardiogram (ECG).
- •Blood pressure over 90/60 mmHg and less than 140/90 mmHg.
- •Be informed of the nature of the study and given written consent prior to receiving any study procedure.
- •Females who are surgically sterile for at least six months or postmenopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up to one month after the end of the study.
- •Females who participate in this study are not pregnant and/or non-lactating.
排除标准
- •Known history or presence of any clinically significant medical condition.
- •Known history of food allergies, or any condition know to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Known or suspected carcinoma.
- •Presence or history of angioedema.
- •Known history or presence of hypersensitivity or idiosyncratic reaction to trandolapril 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.
- •Any clinically significant illness or surgery within 4 weeks prior to drug administration.
- •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 an 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).
- •Use of any prescription medication within 14 days prior to period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to period 1 dosing (except spermicidal/barrier contraceptive products).
- •Use of any drug known to induce or inhibit 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 period 1 dosing.
- •Females taking oral or transdermal hormonal contraceptives within 30 days preceding period 1 dosing OR Females having taken implanted or injected hormonal contraceptives (Depo-Provera) within one year prior to period 1 dosing.
- •Difficulty fasting or consuming the standard meals.
- •Do not tolerate venipuncture.
研究组 & 干预措施
Mavik®
Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
干预措施: Mavik® 4 mg Tablets (Drug)
Trandolapril
Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
干预措施: Trandolapril 4 mg Tablets (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 72 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 72 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 72 hour period
Bioequivalence based on AUC0-t
次要结局
- Cmax - Trandolaprilat(Blood samples collected over 72 hour period)
- AUC0-72 - Trandolaprilat(Blood samples collected over 72 hour period)