An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and
研究概览
简要总结
STUDY TITLE:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500 mcg+10 mg) in healthy adult human subjects under fasting conditions.
Number of subjects: Twenty-four (24) subjects
Duration of clinical study: 35 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive).
- •Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI/CI/Physician.
排除标准
- •Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
- •History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
- •Significant history or current evidence of malignancy or chronic.
- •infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
结局指标
主要结局
1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and
时间窗: From Day 01 to Day 35
Mecobalamine Cmax and AUC0-72.
时间窗: From Day 01 to Day 35
2. To evaluate Pharmacokinetics parameters for Pregabalin Cmax, AUC0-t and AUC0-∞.
时间窗: From Day 01 to Day 35
次要结局
- 1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and(Mecobalamine Tmax.)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited