CTRI/2010/091/001473已完成1 期
An open-label, two-treatment, two-sequence, two-period, balanced, randomized, single dose, cross over, comparative bioavailability study of ZYO1 tablet [20mg tablet and 5mg tablet - old (first) formulation] of M/S Cadila Healthcare Ltd., Ahmedabad, India with ZYO1 tablet [20 mg tablet and 5 mg tablet - new (second) formulation] of M/S Cadila Healthcare Ltd., Ahmedabad, India in healthy, adult, male, human subjects under fasting conditions
Cadila Healthcare Limited,Zydus TowerSatellite Tower,Ahmedabad0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •? Male subjects aged between 18 and 45 years (including both).
- •? Subjects? weight within 15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •? Ability to communicate effectively with study personnel.
- •? Willingness to adhere to the protocol requirements.
- •? Be able to give consent for participation in the trial.
- •? Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range).
排除标准
- •? Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYO1 formulation.
- •? History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
- •? History of depression necessitating hospitalization, two or more recurrent episodes of depression, or suicide attempt.
- •? History or presence of drug addiction or concomitant use of medications known to alter bodyweight or appetite, including anti-obesity drugs, corticosteroids, anti-depressants, neuroleptics, non-selective systemic antihistamines, nicotine substitutes, and antidiabetic drugs in last 30 days.
- •? History or presence of significant alcoholism or drug abuse within the past one-year.
- •? History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products.
- •? Difficulty with donating blood.
- •? Blood pressure less than 100/70 mm Hg or more than 140/90 mm Hg.
- •? Pulse less than 55/minute or more than 110/minute.
- •? Fever or history of fever in last 10 days.
- •? Evidence of active infection or inflammatory process.
- •? Any ECG abnormalities.
- •? Any clinically significant abnormal laboratory values during screening.
- •? Any clinically significant chest X-Ray findings during screening.
- •? Major illness during 3 months before the screening period
- •? Subjects who have participated in drug research studies within past 3 months.
- •? Subjects who have donated one unit (350ml) of blood in the past 3 months.
- •? Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in during both the periods
研究者
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