| Eligibility |
Inclusion Criteria:
To be included in the single dose study, subjects should meet all the following criteria at
the screening visit:
1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
2. Body weight within normal range (Quetelet's index between 19 and 27) expressed as
weight (kg) / height (m2).
3. Normal clinical records and physical examination.
4. Laboratory tests (hematology and biochemistry) within the range of normal values,
according to the Biochemistry laboratory reference values of the 'Hospital de la Santa
Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the
CIM-Sant Pau.
5. Clinically acceptable temperature, blood pressure and pulse rate in supine and
standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between
50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of
resting.
6. Males should agree to abstain from sexual intercourse with a female partner or agree
to use a condom with spermicide, in addition to having their female partner using some
contraceptive measures as oral contraceptive drugs, intrauterine hormonal
contraception, or cervical caps until 28 days post-administration.
7. To be able to understand the nature of the study and comply with all their
requirements.
8. Free acceptance to participate in the study should be stated in an informed consent
document signed by the volunteer which must be approved by the CREC.
For the multiple dose study in healthy male and female volunteers, subjects meeting all the
following inclusion criteria at screening visit:
1. Healthy male and female subjects, 18-45 years (inclusive) of age at the time of
enrolment.
2. Body weight within normal range (Quetelet's index between 19 and 27) expressed as
weight (kg) / height (m2).
3. Normal clinical records and physical examination at screening and baseline.
4. Laboratory tests (hematology, biochemistry and urianalysis) within the range of normal
values, according to the laboratory reference values of the 'Hospital de la Santa Creu
i Sant Pau'. Variations may be admitted according to the clinical criteria of the
CIM-Sant Pau.
5. Clinically acceptable temperature, blood pressure and pulse rate in supine and
standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between
50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of
resting.
6. Males should agree to abstain from sexual intercourse with a female partner or agree
to use a condom with spermicide, in addition to having their female partner using some
contraceptive measures as oral contraceptive drugs, intrauterine hormonal
contraception, or cervical caps until 28 days post-administration.
7. To be able to understand the nature of the study and comply with all their
requirements.
8. Free acceptance to participate in the study by obtains signed informed consent form
approved by the CREC.
9. Females must be of non childbearing potential (i.e. surgically sterile) or have to use
contraceptive measures ( non-hormonal) such as condom, diaphragm or cervical / vault
caps with spermicide until 28 days post administration
Exclusion Criteria:
- For the single dose study and multiple dose study meeting any of the following
criteria at screening visit will be excluded from entry into the study:
1. History of alcohol dependence or drug abuse in the last 5 years or daily
consumption of alcohol > 40 g/day for men and >24g/day for women
2. Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola
drinks per day) and grape juice.
3. Background of idiosyncrasy, food intolerance, hypersensitivity or adverse
reactions to any drug or Galenical form.
4. Presence or history of allergies requiring acute or chronic treatment (except
seasonal allergic rhinitis).
5. Intake of any medication within 2 weeks prior taking the study treatment (except
for use of paracetamol in short-term symptomatic treatments), including
over-the-counter products (including natural food supplements, vitamins and
medicinal plants products), or any enzymatic inductor or inhibitor within 3
months before the drug administration.
6. Positive serology for hepatitis B, C or HIV.
7. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic,
endocrine, gastrointestinal, hematological, neurological disease or other chronic
diseases.
8. History of psychiatric diseases or epileptic seizures.
9. 12 lead ECG obtained at screening with PR = 220 msec, QRS =120 msec and QTc = 440
msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or
any other abnormal changes on the screening ECG that would interfere with
measurement of the QT interval.
10. Having undergone major surgery during the previous 6 months.
11. Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine
patches, etc.) from 6 months prior to drug administration.
12. Participation in other clinical trials during the previous 90 days (drug to drug
period) in which an investigational drug or a commercially available drug was
tested.
13. Donation of blood during the 4 weeks preceding the drug administration.
14. Severe or moderate acute illness 4 weeks before drug administration.
15. Clinically significant abnormal laboratory values (as determined by the PI) at
the screening evaluation.
16. Existence of any surgical or medical condition which might interfere with the
absorption, distribution, metabolism or excretion of the drug, i.e. impaired
renal or hepatic function, diabetes mellitus, cardiovascular abnormalities,
chronic symptoms of pronounced constipation or diarrhea or conditions associated
with total or partial obstruction of the urinary tract
17. Positive results of the drugs at screening period or the day before starting
treatment period. A minimum list of 6 drugs will be screened for inclusion:
Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines
(positive results may be repeated at the discretion of the PI).
18. Female with positive results from pregnancy test or breast-feeding ( only in MAD
stage)
|
