A Phase I, Randomised, Double-Blind, 3-Way Cross-Over Study to Compare the Safety, Tolerability, Pharmacokinetics and Vasodilatory Effect of DRL-21995, DRL 21994 and Niaspan® in Healthy, Adult Male Subjects under Fed Conditions
- Conditions
- high blood fathyperlipidaemia10013317
- Registration Number
- NL-OMON33316
- Lead Sponsor
- Dr. Reddy's Laboratories Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
1. Male, 18-45 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, electrocardiogram (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 the first study drug administration;
5. Use of over-the-counter medication (including homeopathic medicines) within 2 weeks prior to the first study drug administration, 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) or paracetamol 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 drug allergy;
12. Administration of an investigational drug within 90 days prior to the first study drug administration;
13. Loss or donation of >350 mL of blood within 12 weeks prior to the first study drug administration;
14. Unsuitable to participate in the study for any reason in the opinion of the PI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The first is the impact of the investigational drugs and the registered product<br /><br>on safety, tolerability and the release of vessels studied and compared.<br /><br>The second is the speed with which the investigational drugs and the registered<br /><br>product will be absorbed in the body examined, as well as the degree of<br /><br>degradation and excretion of the investigational drugs and its degradation<br /><br>products.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The second is the speed with which the investigational drugs and the registered<br /><br>product will be absorbed in the body examined, as well as the degree of<br /><br>degradation and excretion of the investigational drugs and its degradation<br /><br>products.</p><br>