The aim of the study is twofold. 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…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In this study, DRL-21994 is compared with DRL-21995 and a registered agent
(Niaspan). These three funds are different preparation forms of nicotinic acid
(vitamin B7). DRL-21995 consist also of meloxicam next to nicotinic acid.
An abnormal fat in the blood, particularly cholesterol and triglycerides may
contribute to the development of cardiovascular disease. Cholesterol is divided
into "good" cholesterol (HDL-cholesterol) and "bad" cholesterol
(LDL-cholesterol).
Niaspan has a beneficial effect on fat in the blood. It increases the amount of
HDL cholesterol and lowers the quantities of LDL-cholesterol and triglycerides.
Niaspan is used to a different fat content in the blood, especially at elevated
LDL-cholesterol and triglycerides and reduced HDL-cholesterol (dyslipidemie)
and increased cholesterol in the blood (hypercholesterolemie).
Meloxicam is registered for the management of chronic pain in patients with
osteoarthritis and rheumatoid arthritis. Addition of low doses of Meloxicam to
nicotinic acid may be effective in reduce the most common side effect of
nicotinic accid, flushing.
Study objective
The aim of the study is twofold.
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.
Study design
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.
Intervention
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.
Study burden and risks
The risks associated with this investigation are linked together with the
possible side effects of the investigational product. The burden on the
volunteer will continue to work with the recording periods, assessments
performed during the trial, venapunctions and the introduction of the cannula.
All volunteers are closely monitored and supervised by experienced doctors and
studystaff for possible side effects.
Discovery Research, Bollaram Road
Miyapur, Hyderabad-500 049
IN
Discovery Research, Bollaram Road
Miyapur, Hyderabad-500 049
IN
Listed location countries
Age
Inclusion criteria
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.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012627-29-NL |
| CCMO | NL28304.040.09 |