The aim of the study is twofold. The first is the impact of DRL-21994 and the registered product on the release of vessels studied and compared. The second is the speed with which DRL-21994 is included in the body examined, as well as the degree of…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The impact of DRL-21994 and Niaspin on the release of blood vessels.
Secondary outcome
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 .
Background summary
In this study, the DRL-21994 is compared with a registered agent (Niaspan). The
two funds are different preparation forms of nicotinic acid (vitamin B7).
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).
Study objective
The aim of the study is twofold.
The first is the impact of DRL-21994 and the registered product on the release
of vessels studied and compared.
The second is the speed with which DRL-21994 is included in the body examined,
as well as 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.
Study design
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.
Intervention
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.
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
India
Discovery Research, Bollaram Road,
Miyapur, Hyderabad-500 049
India
Listed location countries
Age
Inclusion criteria
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.
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
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 | EUCTR2009-011376-29-NL |
| CCMO | NL27478.040.09 |