An open label, balanced, randomized, two-treatment, two-period, two-sequence,single oral dose, crossover, bioequivalence study of Doxylamine Succinate 20mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) incomparison with Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} of Duchesnay USA, Inc. in healthy, adult, female subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
STUDY TITLE:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} of Duchesnay USA, Inc. in healthy, adult, female subjects under fasting condition.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) with that of Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended- Release)} of Duchesnay USA, Inc., in healthy, adult, female subjects under fasting condition.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} tablets in healthy, adult, female subjects under fasting condition.
Number of subjects: Thirty two (32)
Duration of clinical study: 34 Days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Study subjects should avoid consuming foods/beverages with high vitamin B6 contents from the time of entry to end of treatment visit
- •Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
- •Willing to be available for the entire study period and to comply with protocol requirements
- •Normal healthy adult female subject of 18 45 years of age
- •Body mass index in the range of 18 30 kg m2.
排除标准
- •Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs
- •History or presence 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
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
时间窗: From Day 01 to Day 34
次要结局
- To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 34)