high blood fat hyperlipidaemia
Conditions
Interventions
One group of 18 healthy male volunteers will participate in this research. The
examination includes a medical examination, 2 admissionperiods of four days and
finally a retesting.
Sponsors
Dr. Reddy's Laboratories Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male, 18-55 years of age at Screening, extremes included; 2. Body mass index (BMI) >= 18 and
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The impact of DRL-21994 and Niaspin on the release of blood vessels. | — |
Secondary
| Measure | Time frame |
|---|---|
| The speed with which DRL-21994 is included in the body and the degree of degradation and excretion of DRL-21994 and its degradation products. Also, The safety and tolerability of DRL-21994 after a single dose of DRL-21994 . | — |
Countries
Netherlands
Outcome results
None listed