CTRI/2018/08/015297尚未招募1 期
A Placebo-Controlled, Randomized, Double Blind, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PNB-001 in Healthy, Adult, Human Male Subjects Under Fasting Conditions
PNB Vesper Life Science Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Non-smokers, Healthy, adult, human male volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- •2. Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg/height in meter square.
- •3. Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- •4. Able to understand and comply with the study procedures, in the opinion of the investigator.
- •5. Able to give voluntary informed consent for participation in the trial.
排除标准
- •1. Known hypersensitivity or idiosyncratic reaction to cholecystokinin receptor antagonist or to any of its excipients or any drug or any substance.
- •2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •3. Sitting blood pressure less than 110/70 mm Hg and/or more than 140/90 mm Hg at the time of screening.
- •4. The presence of abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (SGOT or SGPT) above 1.25 times the upper limit of normal, total bilirubin above the upper limit of normal by at least 10 percentage, or serum creatinine above the upper limit of normal will be admitted to the study at the discretion of the in investigator.
- •5. Values of hematologic function (hemoglobin, hematocrit, white blood cells or platelets) below the lower limit of normal will be admitted to the study at the discretion of the investigator.
- •6. Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), anti-HCV (Hepatitis C Antibody), and HIV.
- •7. Have been previously diagnosed with cancer.
- •8. Ingestion or use of any medication (including herbal remedies) at any time in 2 weeks prior to dosing and 4 weeks for any drug which may affect hepatic drug metabolism. In any such case subject selection will be at the discretion of the Principal Investigator.
- •9. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •10. Consumption of Grapefruits or its products within a period of 72 hours prior to receiving the study drug.
- •11. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percentage distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine.
- •12. Smokers, or who have smoked within last six months prior to start of the study.
- •13. The presence of clinically significant abnormal laboratory values during screening.
- •14. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •15. History or presence of psychiatric disorders.
- •16. Difficulty in swallowing solid dosage forms like tablets or capsules.
- •17. A history of difficulty with donating blood.
- •18. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- •19. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator.
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