NCT02310022已完成1 期
A Pharmacokinetic and Pharmacodynamic Study of Two Formulations of Omega-3 One Gram Capsules After Single and Multi-Dose Administrations 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
- 48
- 试验地点
- 1
- 主要终点
- Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14
研究概览
简要总结
Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator.
详细描述
The primary objective is to determine the comparative bioavailability and pharmacodynamics effects of single and multiple doses of MAT9001 versus an active omega-3 medication comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- •Adult male or female subject, 18-70 years of age, inclusive.
- •Light- or non-smoking, male and female subjects, 18 to 70 years of age. Note: subjects that regularly smoke greater than 10 cigarettes per day will not be considered light-smokers and should not be included. Additionally, the use of any cigars, pipes, vapor inhalers or any other tobacco containing product is prohibited within 6 months prior to drug administration.
- •Body mass index (BMI) ≥ 19 and ≤ 40 (kg/m2).
- •No clinically significant findings in vital signs measurements. The acceptable range for seated systolic blood pressure is 90-150 mmHg and for diastolic blood pressure is 50-95 mmHg.
- •No clinically significant abnormal laboratory values that, in the opinion of the investigator, would compromise the subject's safety or the integrity of the study results.
- •Either have: elevated triglyceride levels (2.26 to 4.52 mmol/L [200 to 400 mg/dL]), or · triglyceride levels 2.26 to 3.95 mmol/L (200 to 350 mg/dL) and are on stable statin therapy.
- •Total cholesterol levels ≤ 7.75 mmol/L (≤ 300 mg/dL).
- •Hemoglobin ≥ 135 g/L for males or ≥ 120 g/L for females at screening.
- •No clinically significant findings in a 12-lead electrocardiogram (ECG)
- •Have no significant diseases.
- •Willing to use an acceptable, effective method of contraception.
- •Be informed of the nature of the study and give written consent prior to any study procedure.
- •Have no clinically significant findings from a physical examination.
排除标准
- •Subjects may be excluded from the study if there is evidence of any of the following criteria at screening, check-in, or at any time during the study, as appropriate:
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the PI.
- •Personal or familial history of bleeding disorder(s), thromboembolic disease, clinical GI bleeding, or any history of GI surgery except uncomplicated appendectomy or cholecystectomy, or colorectal surgery for polyps, nonmalignant tumors, or diverticula.
- •Positive urine drug/alcohol testing at screening or check-in.
- •Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- •History or presence of alcoholism or drug abuse within the past 2 years.
- •Known sensitivity or allergy to fish, shellfish, gelatin or omega-3 products.
- •Subject is a female who is pregnant or lactating.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration
- •Donation of blood or significant blood loss within 56 days prior to check- in.
- •Participation in another clinical trial within 30 days prior drug administration.
研究组 & 干预措施
Drug Omega 3
Experimental
4g (4 capsules) once a day, administered with food Other name MAT9001
干预措施: Drug Omega 3 (Drug)
Drug Omega 3 Comparator
Active Comparator
4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator
干预措施: Drug Omega-3 Comparator (Drug)
结局指标
主要结局
Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14
时间窗: 14 Days
Area under the plasma concentration curve versus time curve (AUC0-tau) versus time curve (AUC0-tau) for both treatments measured over the 24 hour period on day 1 and day 14 \[ Time Frame: 14 days \]
次要结局
- Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days(14 Days)
研究者
研究点 (1)
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