NCT01990586已完成1 期
An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Rabeprazole Sodium Delayed Release Tablets 20 mg (Test, Torrent Pharmaceuticals Limited., India) Versus Aciphex® (Rabeprazole Sodium) Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA) in Healthy Human Volunteers Under Fed Condition.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- bioequivalence based on Composite of Pharmacokinetics
研究概览
简要总结
Objective:
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period during fed study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male human volunteers within the age range of 18 to 50 years
- •A body mass index within 18-25 Kg/m2
- •Given written informed consent to participate in the study
- •Absence Of disease markers of HIV 1& 2, hepatitis B & C virus and RPR.
- •Absence of significant disease or clinically' significant abnormal laboratory values on laboratory evaluation, medical history and medical examination during the screening
- •A normal 12 lead ECG.
- •A normal chest X-ray (FA view)
- •Comprehension of the nature and purpose'of the study and compliance with the requirement of the entire protocol
- •No history or no evidence of hypersensitivity to rabeprazole substituted benzimidazoles or to any component of the formulation
- •No history of Anaphylaxis arid Angioedema
- •No history or presence of gastric malignancy
- •No history of significant systemic diseases
- •No history of psychiatric disorders
- •No history of addiction to any recreational drug or drug dependence
- •No donation of blood(one unit or 350 mL) within 90 days prior to study check-in
- •No participation in any clinical study within the last 90 days
- •No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations' vitamins and natural products used for therapeutic benefits), within two weeks prior to study check-in
- •No history of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to study check-in
- •No family history of neurological disorders
- •Not consumed alcohol and xanthin containing food and beverages, (chocolates, tea,coffee or cola drinks) cigarettes and tobacco products for at least 48.0 hours prior to study check-in for each period.
- •Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Cannabinoids and Barbiturates) in urine during the day of study check-in of each period
- •Not consumed grapefruit(mosumbi/sweet lime) juice within the 48.0 hours prior to study check-in
- •Negative alcohol breath analysis during the study check-in of each period
排除标准
- •History of seizures
- •Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
- •History of alcohol consumption for more than two units/day (1 unit=30 mL of spirit/or 1 pint of beer), or having consumed alcohol within 48.0 hours prior to check-in
- •High caffeine (more than 5 cups of coffee or tea/day) or tobacco (mote than 9 cigarettes/beedies/cigars per day) consumption
- •History of difficulty with donating blood or difficulty in accessibility of veins
- •An unusual or abnormal diet for whatever reason e.g. because of fasting due to religious reasons
结局指标
主要结局
bioequivalence based on Composite of Pharmacokinetics
时间窗: plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted ConditionsHealthyNCT01928056Torrent Pharmaceuticals Limited
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fed ConditionHealthyNCT01996501Torrent Pharmaceuticals Limited
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed ConditionsHealthyNCT01928069Torrent Pharmaceuticals Limited
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted ConditionsHealthyNCT01990378Torrent Pharmaceuticals Limited
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting ConditionHealthyNCT01996462Torrent Pharmaceuticals Limited