CTRI/2025/10/096497已完成不适用
A Randomized, Open Label, Single dose, Parallel Bioavailability Study of ZY-19489 300mgX3 capsules vs 900 mg single tablet Administered Via Oral Route in Healthy Adult Human Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the bioavailability of ZY-19489 tablet with ZY-19489 capsule administered to healthy participants.
研究概览
简要总结
This is randomized, open label, single dose, parallel, bioavailability study of ZY-19489 900 mg tablet with ZY-19489 300 mg * 3 capsules of Zydus Lifesciences Ltd. Administered orally to healthy human adult subjects aged 18-50 years, inclusive.
After confirmation of the eligibility, subjects will be admitted in the clinical unit on Day (-1). Study drug will be administered on Day 0 after overnight fast. Eligible subjects will receive a single dose of ZY-19489 900 mg [ZY-19489 900 mg tablet or ZY-19489 900 mg (300 mg* 3) capsules of Zydus Lifesciences Ltd.] as per the randomization schedule.
After dosing on day 0, each subject will remain confined within the clinical unit for 48 hours post dose for safety assessments and blood sampling for PK analysis. Subject will report to the clinical facility on Day 3, Day 5, Day 7, Day 14 and Day 28 as ambulatory visits.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and/or non-pregnant, non-lactating female subjects aged between 18 and 50 years (Both inclusive). 2.Male subjects and/or female subjects of childbearing potential must agree to use effective contraception till study completion. 3.Body weight greater than 50 kg and BMI within the range greater than equal to 18.
- •less than equal to 29.9 kg/m2 (Both inclusive). 4.Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol. 5.Ability to communicate effectively with study personnel. 6.Participants who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator.
排除标准
- •1.History of alcohol consumption or tobacco use or drug abuse within the past 1 year of enrollment or subject’s currently taking alcohol and/or tobacco products.
- •2.Difficulty with donating blood or Inability to be venipuncture or tolerate venous puncture 3.Systolic blood pressure more than 140 mmHg or less than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg. 4.Pulse rate less than 55/minute or more than 100/minute.
- •5.Any clinically significant laboratory or ECG findings during screening as per discretion of investigator.
- •6.Surgery within last 3 months or planned major surgery within next 3 months from the date of screening.
- •7.Any major illness during last 3 months as per Investigator discretion.
- •8.Volunteers who have participated in any drug research study within past 3 months.
- •9.Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
- •10.History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reactions.
- •11.Subjects not willing to use contraceptives till completion of the study.
- •12.Subjects who are found positive urine alcohol test or urine test for drug of abuse at the time of check in.
- •13.Female subjects with history of pregnancy or lactation in the past 3 months 14.Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures.
- •15.Difficulty in swallowing of tablet or capsule.
- •16.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug.
- •17.Participants who have recent illness (eg, fever) within 14 days of enrollment.
- •18.Consumption of beverages or food containing xanthene bases including red bull, chocolate, coffee, etc.
- •from 48 hours prior to enrollment.
- •19.Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. Diarrhoea).
- •20.Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participants unsuitable for the study.
结局指标
主要结局
To compare the bioavailability of ZY-19489 tablet with ZY-19489 capsule administered to healthy participants.
时间窗: Day 0 to Day 28
次要结局
- To assess the safety and tolerability of ZY-19489.(Day 0 to Day 28)
研究者
Dr Deven Parmar
Zydus Lifesciences Ltd
研究点 (1)
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