CTRI/2026/01/101997尚未招募1 期
A drug-drug interaction study of Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule)] and Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL, (equivalent to 10 mg/mL of caffeine base) (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Each mL contains 2 mg of Midazolam base) (Dose = 2 mg) and Bupropion 75mg Tablet] in healthy adult human subjects under fasting conditions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
研究概览
简要总结
An open label, non-randomized, three-period, two-treatment, single-sequence, a drug-drug interaction study. The study will be conducted in three-period.
Period I: Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 01.
Period II: Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule] will be administered twice a day (morning & evening) on Day 01 and once a day in the morning on Day 02 and Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 02.
Period III: Treatment A [Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule] will be administered twice daily (morning & evening) for 13 days and once a day in the morning on Day 14 and Single dose administration of Treatment B [Caffeine Citrate Oral Solution, USP 20 mg/mL (Dose = 100 mg of Caffeine base), Midazolam Hydrochloride syrup 2mg/mL (Dose = 2 mg) and Bupropion 75mg Tablet] in the morning on Day 14.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or non-pregnant, non-lactating female.
- •Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test performed within 28 days of the first dose of study medication.
- •They must be using an acceptable form of contraception.
- •18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point.
- •Able to communicate effectively with study personnel.
- •Non-smokers, non-tobacco and non-alcoholic users (i.e. having no past history of alcoholism, smoking and tobacco consuming for at least one year prior to study) 6) Willing to provide written informed consent to participate in the study.
- •All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication.
排除标准
- •History of allergic responses to Caffeine, Bupropion & Midazolam or other related drugs, or any of its and usnoflast formulation ingredients.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording and Chest X-ray, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
- •Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- •History or presence of respiratory conditions (i.e., moderate to severe asthma, chronic obstructive pulmonary disease [COPD], etc.).
- •Use of any hormone replacement therapy within 3 months prior to Period 1 dosing.
- •Use of any depot injection or implant of any drug within 3 months prior to Period 1 dosing.
- •History or evidence of drug dependence.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody.
- •Volunteer who have received a known investigational drug within seven elimination half-life of the administered drug prior to Period 1 dosing.
- •History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- •Intolerance to venipuncture.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study.
- •Institutionalized volunteer 17)Use of any prescribed medications within 30 days prior to Period 1 dosing.
- •Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to Period 1 dosing.
- •Use of grapefruit and grapefruit containing products within 7 days prior to Period 1 dosing.
- •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and except protocol defined drug B1 (Caffeine Citrate Oral Solution) administration, recreational drugs within 72 hours prior to Period 1 dosing.
- •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to Period 1 dosing.
- •SGOT, SGPT and alkaline phosphatase values are 1.1 times higher than the upper limit of normal range during screening.
- •Serum bilirubin values are higher than the upper limit of normal range during screening.
- •Serum creatinine higher than upper limit during screening 25) History or symptoms of narrow angle glaucoma.
- •History of head trauma.
- •History or presence of seizure, epilepsy, central nervous system (CNS) tumor, bulimia, anorexia nervosa.
- •History or presence of severe hepatic cirrhosis.
研究者
Dr Deven V Parmar MD FCP
Zydus Lifescience Ltd
研究点 (1)
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