high blood fat hyperlipidaemia
Conditions
Interventions
18 healthy male volunteers will participate in this research. The examination
includes a medical examination, 3 admissionperiods of five days and finally a
follow up.
Sponsors
Dr. Reddy's Laboratories Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male, 18-45 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first is the impact of the investigational drugs and the registered product on safety, tolerability and the release of vessels studied and compared. The second is the speed with which the investigational drugs and the registered product will be absorbed in the body examined, as well as the degree of degradation and excretion of the investigational drugs and its degradation products. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second is the speed with which the investigational drugs and the registered product will be absorbed in the body examined, as well as the degree of degradation and excretion of the investigational drugs and its degradation products. | — |
Countries
Netherlands
Outcome results
None listed