CTRI/2022/06/043281已完成不适用
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 GITS TABLETS MINIPRESS®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t and AUC0-∞ of prazosin
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 GITS TABLETS 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
- 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
- All
入选标准
- •Normal healthy human adult male and/or female volunteers aged between 18-45 years (both ages inclusive).
- •Volunteer 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).
- •A total body weight >50 kg (110 lb).
- •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 urine), negative urine drugs of abuse test.
- •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 2 days prior to dosing, during the study & for 07 days following their last dose of IP.
- •Male volunteers and/or female volunteer’s partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study & for 07 days following their last dose of IP.
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 motherslactating women or are found positive in beta hCG test.
- •History/presence of significant alcohol dependence (abuse) or drug abuse within past 1 year, current alcohol abuse (greater 5 units/week, 1 unit equal to 10 mL or 8 g of pure alcohol) or suspected abuse.
- •Who is every day smoker (who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day) or consumption of tobacco products.
- •History/presence of asthma.
- •History/presence of urticaria or other allergic type reactions after taking any medication.
- •History/presence 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 100 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.
- •With Diastolic blood pressure less than 60 mm of Hg or more than 90 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
Cmax, AUC0-t and AUC0-∞ of prazosin
时间窗: Assessed after dosing at 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 16.00 hours and during each ambulatory visit in each study period.
次要结局
- tmax, t½ and Kel of prazosin.(Adverse events (AEs).)
研究者
研究点 (1)
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