CTRI/2020/12/029980尚未招募不适用
An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose oral bioequivalence study of Itraconazole oral solution (10mg/mL) (T) Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli- Kalan, Industrial Town Ship, Baddi with Sporanox (Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK, in normal healthy, adult male subjects under fasting condition.
GC CHEMIE PHARMIE LIMITED1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年12月30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
- 24
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Itraconazole oral solution (10mg/mL) (T) of Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli-Kalan,Industrial Town Ship, Baddi with Sporanox(Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK
研究概览
简要总结
An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose oral bioequivalence study of Itraconazole oral solution (10mg/mL) (T) Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli- Kalan, Industrial Town Ship, Baddi with Sporanox (Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK, in normal healthy, adult male subjects under fasting condition.
It is a Biequivalence study recommended by CDSCO for subsequent New Drug approval purpose
研究设计
- 研究类型
- Interventional
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy adult subjects between 18-45 years (both inclusive) of age, having a Body Mass Index between 18.50 –24.99 kg/m2(both inclusive), healthy according to medical history, clinical examination, laboratory evaluations, 12-lead ECGwith chest X-ray (valid for 01 year), haematology, biochemistry, serology (HIV, VDRL/RPR, HepatitisB and C tests), urine analysis will be performed for all subjects.
- •Subjects preferably should be non-smokers and without a history of alcohol or drug abuse.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.History of allergic reaction to heparin.History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.Systolic blood pressure less than90 mmHg or more than 140 mmHg at the time of screening.
- •Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening.
- •Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.Pulse rate below60 beats/minute or above 100 beats/minute at the time of screening.Respiratory rate below 15 or above 20 breaths per minute.Oral temperature below 96.2oF or above 99.8 o F at the time of screening.
- •Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
- •In any such case subject selection will be at the discretion of the principal investigator.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-inof each period.An unusual or abnormal diet within 48.00 hours prior to study check-inof each period, whatever reason e.g. because of fasting due to religious reasons.The presence of clinically significant abnormal laboratory values during screening.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.Positive HIV, VDRL/RPR, Hepatitis B and C tests.Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria Form (Attachment 1 to this protocol) for each volunteer.
- •Only suitable volunteers should be allowed to participate in the study.
结局指标
主要结局
To compare the rate and extent of absorption of Itraconazole oral solution (10mg/mL) (T) of Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli-Kalan,Industrial Town Ship, Baddi with Sporanox(Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK
时间窗: 8 weeks
次要结局
- To monitor the adverse events and to ensure the safety of the subjects following administration of a single dose of Itraconazole oral solution.(2 MONTHS)
研究者
研究点 (1)
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