| Criteria: |
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Inclusion Criteria:
- Subject is healthy between the ages of 18-55 years of age
- Female subjects must weigh between 55 and 100 kg, with a BMI between 19.0-29.9.
kg/m2; inclusive at screening. Male subjects must weigh between 55 and 120 kg, with
a BMI between 19.0-32.0 kg/m2; inclusive at screening.
- Subject has a medical history, physical examination, vital signs, ECG and clinical
laboratory results within normal limits or considered not clinically significant by
the Investigator at Screening.
- Female subjects with childbearing potential will practice abstinence or effective
birth control methods from the time of providing written informed consent to the end
of the study. Effective birth control is defined as an intrauterine device (IUD),
barrier methods preferably in combination with a spermicidal foam or suppository, or
the use of oral, transdermal or intra-vaginal hormonal contraceptives.
- Subject agrees to abstain from taking any prescription medication (except
contraceptives) for 14 days prior to starting study procedures and to abstain from
taking any non-prescription medications (except multivitamins) or herbal supplements
for 7 days prior to beginning study procedures until discharge from the study (unless
prescribed by the Investigator to treat an AE).
- Subject agrees to abstain from consuming alcohol from 3 days prior beginning study
procedures until discharge from the study.
- Subject agrees to abstain from consuming grapefruit or xanthine-containing food or
beverages for 3 days prior beginning study procedures until discharge from the study.
- Subject agrees to refrain from strenuous exercise from beginning study procedures
until discharge from the study.
- Subject is able to communicate effectively with study personnel and be considered
reliable, willing and cooperative in terms of compliance with the protocol
requirements.
Exclusion Criteria:
- Subject has any clinically relevant abnormality identified during the screening
physical examination, 12-lead ECG, or laboratory examinations.
- Subject has a history of anaphylaxis, a previous documented hypersensitivity
reaction, or a clinically significant idiosyncratic reaction to any drug.
- Subject has a clinically significant history of neurological, cardiovascular,
respiratory, endocrine, hematological, hepatic, renal, gastrointestinal,
genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric
disorder, or any other chronic disease, whether controlled by medication or not.
- The subject has a history of postural hypotension, unexplained syncope, a blood
pressure that is less than 85 mmHg systolic or 50 mmHg diastolic, or a pulse rate
that is greater than 90 bpm after sitting at rest for 5 minutes at Screening or
Baseline.
- Subject has a predisposing condition that could interfere with the absorption,
distribution, metabolism, or excretion of drugs.
- Subject has tested positive at the screening visit for HIV infection, HBsAg, or the
HCV antibody.
- Subject is pregnant or lactating.
- Subject currently uses tobacco products or has a history of tobacco use within six
months prior to Period 1.
- Subject has a history of alcohol abuse or a history of or current impairment of organ
function reasonably related to alcohol abuse.
- Subject has a history of or current evidence of abuse of licit or illicit drugs or a
positive urine screen for drugs of abuse.
- Subject has a history of abnormal bleeding tendencies.
- Subject has donated blood or plasma or has lost a significant volume of blood
(greater than 450 mL) within four weeks prior to Period 1.
- Subject has participated in any investigational drug study within 30 days prior to
Screening. |