CTRI/2025/11/098004招募中不适用
Single dose oral food effect bioavailability study of Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule) in healthy adult human subjects under fasting and fed conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
An open label, randomized, two-period, two-treatment, [Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)], two-sequence, crossover, balanced, single dose oral food effect bioavailability study. At least 11 hours prior to dosing until at least 24 hours post dose in each period.Considering the minimum washout period, expected study duration of clinical part is 11 days from the day of check-in of first period. Subject will remain seated upright for initial 04 hours post-dose and only necessary movement will be allowed during this period. In each period, total 20 venous blood samples (04 mL each) will be collected at pre-dose (0.0 hour) and at 0.25, 0.5, 0.75, 1.0, 1.333, 1.667, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0 and 48.0 hours post dose.
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
- •Able to communicate effectively with study personnel.
- •Non-smokers, non-tobacco and non-alcoholic users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study) 3) 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 any drugs or any of usnoflast formulation ingredients.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, 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 bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- •Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •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 the first dose of study medication.
- •History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- •Intolerance to venipuncture 14) 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.
- •Use of any prescribed medications within 14 days prior to the first dose of study medication.
- •Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- •Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
- •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- •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.
研究者
Dr Deven Parmar
Zydus Lifesciences Ltd
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Food Effect Study of LY03020 in Healthy SubjectsSchizophreniaNCT07292233Luye Pharma Group Ltd.16
已完成
1 期
Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating TabletsMajor Depressive Disorder (MDD)NCT05416957Seasons Biotechnology (Taizhou) Co., Ltd.24
尚未招募
不适用
A study to find out how MB EnzymePro® Capsule affects the absorption of whey protein in healthy adult men under fasting conditions.CTRI/2025/11/097046Bright Lifecare Pvt. Ltd. (Healthkart)84
招募中
1 期
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult ParticipantsNCT07334080Eccogene72
尚未招募
1 期
Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release TabletsT2DM (Type 2 Diabetes Mellitus)NCT07511010Chipscreen Biosciences, Ltd.28