An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Esomeprazole Mg DR Capsule 40 mg [Torrent,India] Versus Nexium 40 mg DR Capsule [ AastraZeneca LP, USA] in Healthy Subjects-Fed Condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Cmax
研究概览
简要总结
Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.
详细描述
An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg [Test Formulation, Torrent Pharmaceutical Ltd., India]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. [Reference Formulation, AastraZeneca LP, USA] in Healthy Human Volunteers Under Fed Conditions.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: male
- •Age: 18-45 years
- •Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- •Healthy and willing to participate in the study.
- •Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- •Non-smokers or smoker who smokes less than 10 cigarettes per day.
排除标准
- •Inability to communicate or co-operate.
- •Administration of any study drug in the period 0 to 3 months before entry to the study,
- •History of significant blood loss due to any reason, including blood donation in the past 3 months.
- •Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- •History of pre-existing bleeding disorder.
- •Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •Clinically significant abnormal ECG or Chest X-ray.
- •HIV, HCV, HBsAg positive volunteers.
- •History of alcohol or drug abuse.
- •History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
- •Positive to Breath alcohol test.
- •Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- •Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 50/minute or more than 100/minute.
- •Oral temperature less than 35°C or more than 37.5°C.
- •Respiratory rate less than 12/minute or more than 20/minute.
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •Recent History of kidney or liver dysfunction.
- •Volunteers suffering from any psychiatric (acute or chronic) disorder.
- •Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
研究组 & 干预措施
Test
Torrent's Esomeprazole Magnesium DR Capsules 40 mg
干预措施: Torrent's Esomeprazole Magnesium DR Capsules 40 mg (Drug)
Reference
Nexium 40 mg DR Capsules of AstraZeneca LP, USA
干预措施: Nexium 40 mg DR Capsules of AstraZeneca LP, USA (Drug)
结局指标
主要结局
Cmax
时间窗: Pre dose to 24 hour post dose
Pharmacokinetic Evaluation
AUC
时间窗: Pre dose to 24 hour post dose
Pharmacokinetic Evaluation
次要结局
未报告次要终点