A Phase I randomised, double-blind, 2-way cross-over study to compare the peripheral vasodilatation following treatment with DRL 21994 or NIASPAN® and to determine the pharmacokinetics of DRL 21994 in healthy, adult male subjects under fed conditions. - Study Protocol DRL21994/CD/001

Dr. Reddy's Laboratories Ltd.0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年5月6日

研究概览

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•1. Male, 18-55 years of age at Screening, extremes included;
•2. Body mass index (BMI) >= 18 and <= 30 kg/m2;
•3. Venous access sufficient to allow blood sampling as per protocol;
•4. Ability and willingness to give written informed consent;
•5. Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory profiles of both blood and urine.

•1. Positive for hepatitis B, C or HIV;
•2. Positive drug screen result (i.e. cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines, and/or methadone);
•3. Positive alcohol breath test result;
•4. Use of prescription medication within 4 weeks prior to Day 1;
•5. Use of over-the-counter medication (including homeopathic medicines) within 2 weeks prior to Day 1, including routine vitamins. Regular use of non-drug therapies such as garlic supplementation and St John*s Wort;
•6. Use of non steroidal anti inflammatory agents (e.g. aspirin, ibuprofen) within 2 weeks of treatment;
•7. Presence or history of alcoholism or drug abuse;
•8. History or diagnosis of clinically significant haematological, hepatic, renal, cardiovascular, neurological, endocrinological, oncological, psychiatric or any other major medical illness;
•9. Use of more than 21 units of alcohol per week;
•10. Smoking (subjects have to be non-smokers for at least 3 months preceding Screening);
•11. History of clinically significant allergies, including relevant drug hypersensitivity or allergy;
•12. Administration of an investigational drug within 90 days prior to Day 1;
•13. Loss or donation of >350 mL of blood within 12 weeks prior to Day 1;
•14. Unsuitable to participate in the study for any reason in the opinion of the PI.

发起方

Dr. Reddy's Laboratories Ltd.