Single dose oral food effect bioavailability study of Saroglitazar Magnesium tablets 1 mg in healthy adult human participants under fasting and fed conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
A Single dose oral food effect bioavailability study of Saroglitazar Magnesium tablets 1 mg in healthy adult human participants under fasting and fed conditions.
Participants will receive one of the treatments mentioned below in each study period as per the randomization schedule.
Treatment A - Investigational product administration under fasting condition.
Treatment B - Investigational product administration under fed condition.
Treatment A - For fasting condition:
Test product Saroglitazar Magnesium tablets 1 mg will be administered orally to the participants as per the randomization schedule in a sitting posture with about 240 mL of water at ambient temperature in each period
Treatment B - For fed condition:
Test product Saroglitazar Magnesium tablets 1 mg will be administered orally 30 minutes after starting the standardized high-calorie and high-fat breakfast to the participants as per the randomization schedule in a sitting posture with about 240 mL of water at ambient temperature in each period under the supervision of trained study personnel.
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 2)BMI:18.5 to 30.0 kg/m2, both inclusive 3)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) 5)Willing to provide written informed consent to participate in the study.
- •All participants 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 Saroglitazar or other related drugs, or any of its 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 participants)].
- •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.
- •Use of CYP enzyme inhibitors or inducers within 30 days 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.
- •Participant who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- •Participant who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or greater than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- •Intolerance to venipuncture 16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant’s participation in this study.
- •Institutionalized participant.
- •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 caffeinecontaining 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.
- •Participant having sitting systolic blood pressure less than 100 mmHg or greater than 140 mmHg or sitting diastolic blood pressure less than 60 mmHg or greater than 90 mmHg and pulse rate less than 60 or greater than 100 per minute during screening.
研究者
Dr Deven Parmar
Zydus Lifesciences Ltd