- Only healthy volunteers, between the ages of 18 and 40 years, will be included.
- Subjects' body mass index must be between 19-27.
- Volunteers must be in good health, as determined by the results of a complete
clinical history prepared by doctors at the clinical research site and laboratory
tests performed at certified clinical laboratories.
- Volunteers must agree to use at least two birth control methods (except hormonal
contraceptives) from the first dose of the study drug and for up to 28 days after the
last dose. (acceptable methods are surgically definitive sterilization, menopause,
barrier methods such as condoms and diaphragm, and spermicidal gels/foams)
- The limits of variation permitted within normality at the screening visit will be:
blood pressure (seated) 90 to 130 mm Hg systolic and 60 to 90 mm Hg diastolic, heart
rate between 55 and 100 beats per minute and respiratory rate between 14 and 20
respirations per minute.
- The laboratory and cabinet tests required to include subjects in the studio will be:
1) Hematology: hemoglobin, hematocrit, total white blood cell count with
differential, and platelet count, 2) 27-element blood chemistry, 3) Markers for
hepatitis B and C. 4) Detection of HIV, 5) General urinalysis, 6) Drug abuse test in
both study periods, 7) Qualitative pregnancy test in both study periods (if
applicable) , 8) Electrocardiogram. (pre-screening/recruitment)
- Subjects in whom any alteration is detected in their vital signs recorded at the
screening of volunteers.
- Volunteers who fail to comply with the established criteria for inclusion.
- Volunteers with antecedents of cardiovascular, renal, hepatic, muscular, metabolic,
and gastrointestinal disorders, including constipation; neurological, endocrine, and
hematopoietic disorders; or any kind of anemia, asthma, mental illness, or other
organic abnormalities, as well as those who have suffered a muscular traumatism
within 21 days before the study.
- Volunteers who require any medication over the course of the study, aside from the
drug being studied.
- Volunteers with antecedents of dyspepsia, gastritis, esophagitis, and duodenal or
- Volunteers who have been exposed to known hepatic enzyme inductors or inhibitors or
have taken potentially toxic drugs within 30 days before the start of the study.
- Volunteers who have received any medication within 14 days or 5 half lives (whichever
is longer) before the start of the study.
- Volunteers who have been hospitalized for any problem within seven months before the
start of the study.
- Subjects who have received investigational drugs within 60 days prior to the study.
- Subjects allergic to any antibiotic and/or non-steroidal antiinflammatory analgesics.
- Subjects who have consumed alcohol or xanthine containing beverages (coffee, tea,
cocoa, chocolate, mate, colas) or have consumed charcoal broiled foods or grapefruit
juice within one week before the start of the study and until the last sample is
- Subjects who have donated or lost 450 mL or more of blood within 60 days before the
start of the study.
- History of regular consumption of alcohol exceeding 14 drinks/week (1 drink = 5
ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of liquor
within 6 months before the screening visit.
- Excessive use of products containing tobacco or nicotine, equivalent to 5 cigarettes
- Female volunteers with positive results on the pregnancy test or in lactation.
- Volunteers who require a special diet for any reason, for example vegetarians.
- Disability of any kind that prevents the volunteer from understanding the nature,
purpose, and potential consequences of the study.
- Evidence of an uncooperative attitude during the study.
- Female volunteers in lactation.
- Female volunteers who receive oral contraceptives