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 - PRTE1001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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
- •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
- •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.
- •q) A positive test result for HIV (I & II) antibody.
- •r) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IMP
- •in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- •s) Difficulty in swallowing tablets or other oral solid dosage forms.
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