CTRI/2025/04/083888尚未招募不适用
A randomized, open label, balanced, two treatment, two period, two sequence, cross over, single dose bioequivalence study of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India comparing with Prazosin Hydrochloride Minipress®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions.
Pfizer Limited,1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年4月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to compare the single dose bioequivalence of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India with Prazosin Hydrochloride Minipress®XL GITS Tablets 5 mg of Pfizer Pharmaceuticals LLC, USA in healthy human adult subjects under fasting conditions
研究概览
简要总结
A randomized, open label, balanced, two treatment, two period, two sequence, cross over, single dose bioequivalence study of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India comparing with Prazosin Hydrochloride Minipress®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy human adult volunteers aged between 18-45 years (both ages inclusive).
- •Volunteers provided written informed consent and are willing to participate in the study.
- •Volunteer with Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive).
- •No evidence of underlying disease during pre-study screening, medical history, physical examination, and laboratory investigations done within 21 days prior to commencement of the study.
- •Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
- •Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
- •Negative test results for alcohol (in breath), negative urine drugs of abuse test.
- •Non-smoker, non-tobacco (in any form) users.
- •12 lead ECG recording either normal or within acceptable limits or considered by the Investigator to be of no clinical significance with respect to his/her participation in the study.
- •Normal or clinically non.
- •significant chest X-ray (PA) taken within 06 months before the day of dosing.
- •Available for the entire study and capable of understanding instructions and communicating with the investigators and clinical study facility staff.
- •Female volunteers who is having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in.
- •Females with child-bearing potential must agree to use an acceptable method of contraception at least 02 days prior to dosing, during the study & for 07 days following their last dose of IP.
- •Male subjects and/or Female subject’s partner who has not undergone vasectomy, must agree to use condoms, or spermicide in addition to female contraception for additional protection against conception during the study and for 07 days following their last dose of the study medication.
排除标准
- •Known allergy to Prazosin Hydrochloride or any component of the formulation and to any other related drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •Female volunteers who are nursing mothers or are found positive in beta hCG test.
- •History of significant alcohol dependence (abuse) or drug abuse within past 1 year, current alcohol abuse or suspected abuse.
- •History of smoking, even single cigarette, bidis or any other form
- •History of asthma.
- •History of urticaria or other allergic type reactions after taking any medication.
- •History of clinically significant illness within 04 weeks before the start of the study.
- •History of significant Hypersensitivity to heparin.
- •History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
- •Scheduled for surgery any time during study or within 07 days after study completion.
- •History of difficulty in donating blood.
- •With unsuitable veins for repeated venipuncture.
- •Participation in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
- •Consumption of prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing in Period 1, including topical medication.
- •Hospitalization within 28 days prior to administration of the study medication.
- •History of difficulty in swallowing.
- •Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial.
- •With Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
结局指标
主要结局
The primary objective of this study is to compare the single dose bioequivalence of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India with Prazosin Hydrochloride Minipress®XL GITS Tablets 5 mg of Pfizer Pharmaceuticals LLC, USA in healthy human adult subjects under fasting conditions
时间窗: The samples for measurement of PK outcome will be drawn at baseline, third day and eleventh day.
次要结局
- The secondary objective of this study is to monitor the safety & tolerability of a single dose Prazosin Hydrochloride Sustained Release tablets 5 mg when administered in healthy human adult subjects under fasting conditions.(Safety monitoring will be done at baseline & at each dosing day. Total duration of study is 11 days.)
研究者
Dr Pradeep Kundapur
Ecron Acunova Limited (formerly known as Manipal Acunova Limited),
研究点 (1)
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