CTRI/2018/06/014352已完成1 期
AN OPEN-LABEL, BALANCED, RANDOMIZED, TWO-PERIOD, TWO-SEQUENCE, TWOTREATMENT CROSS-OVER BIOEQUIVALENCE STUDY OF TEST PRODUCT AVOMINE MD (PROMETHAZINE THEOCLATE ORALLY DISINTEGRATING TABLET 25 MG) VERSUS REFERNCE PRODUCT AVOMINE® UNCOATED TABLETS (25 MG) UNDER FASTING CONDITIONS IN HEALTHY HUMAN MALE SUBJECTS
Abbott Healthcare Private Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- test product versus single oral administration of reference product under fasting conditions in
研究概览
简要总结
The purpose of the study is to evaluate bioequivalence after single oral administration of test product versus single oral administration of
reference product under fasting condition in healthy adult human male subjects.
Study completed.
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
- Male
入选标准
- •a) Non smoker, non-alcoholic, healthy adult human male subjects between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- •b) Having a Body Mass Index (BMI) between 18.5 and 30 (both inclusive), calculated as weight in kg/ height in meter sqaure.
- •c) Subject weight should be more than 50 kg at the time of screening.
- •d) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (Postero-anterior view) recordings.
- •e) Able to understand and willing to comply with the study procedures, in the opinion of the Principal investigator.
- •f) Subjects who are able and willing to give written informed consent.
排除标准
- •a) Known hypersensitivity or idiosyncratic reaction to Promethazine or any other similar/ related drugs.
- •b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •c) Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats per minute at the time of screening d) Presence of orthostatic hypotension at screening.
- •e) History of major surgery within 4 weeks prior to receiving study medicine in period-I.
- •f) Ingestion of a medication (including prescribed and/or non-prescribed, systemic and/or topical medication including herbal supplements/medicines) from 14 days prior to dosing of Period-I.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •g) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period-I.
- •i) Smokers, or who have smoked within last six months prior to start of the study.
- •j) Consumption of grapefruit or grapefruit products within a period of 72 hours prior to dosing in period-I.
- •k) The presence of clinically significant abnormal laboratory values during screening.
- •l) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •m) History or presence of psychiatric disorders.
- •n) A history of difficulty in donating blood.
- •o) Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medicine.
- •Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- •Note: In case the blood loss was less than or equal to 200 mL; subject may be enrolled 60 days after blood donation or after the last sample of previous study.
- •p) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •s) Difficulty in swallowing tablets or other oral solid dosage forms.
结局指标
主要结局
test product versus single oral administration of reference product under fasting conditions in
时间窗: Pre-dose- 11 hours | Post-dose- 24 hours
healthy adult human male subjects.
时间窗: Pre-dose- 11 hours | Post-dose- 24 hours
The primary objective of this study is to evaluate bioequivalence after single oral administration of
时间窗: Pre-dose- 11 hours | Post-dose- 24 hours
次要结局
- To assess the safety and tolerability of Promethazine theoclate following single oral administration of test product versus single oral administration of reference product in healthy adult human male subjects.(Pre-dose- 11 hours)
研究者
研究点 (1)
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