| Eligibility |
Inclusion Criteria:
-Male or female, ages 18 to 45 years, inclusive. -Healthy as determined by screening
medical history, medication history, and absence of acute illness such as gastrointestinal
or respiratory infection. -Capable of understanding, consenting and complying with the
entire study protocol. -Provide voluntary written Informed Consent. -Females of
childbearing potential are required to utilize an appropriate method of contraception
[abstinence, oral contraceptives, IUD, condoms with spermicidal foam, surgical
sterilization depots and injectable contraceptives, or diaphragms with spermicidal jelly or
cream] 30 days prior to the Week 12 visit.
Exclusion Criteria:
-Chronic diarrhea, inflammatory bowel disease, irritable bowel syndrome, or other
gastrointestinal disorder, gastrointestinal surgery (except appendectomy, polypectomy, or
herniorraphy), or severe chronic illness such as major organ failure, diabetes, HIV/AIDS.
-Female who is pregnant or lactating; or a female subject with a positive urine pregnancy
test determined at the Week 12 visit. -History of hypersensitivity to Ciprofloxacin, any
member of the quinolone class of antimicrobial agents, or any compound of the product.
-History of tendinitis or tendon rupture. -History of seizures other than febrile seizure
as a young child. -Treatment with antibiotics within one month before the initial specimen
collection. -History of clinically significant acute or chronic illness or other condition
requiring chronic medication therapy (including systemic but not intranasal steroids),
except for birth control pills, inhalers, anti-anxiety or anti-depression medications.
-History of cardiac rhythm abnormalities or QT prolongation or a family history of cardiac
rhythm abnormalities or sudden unexplained death. -History of current or past use of
theophylline for asthma or tizanidine, due to known interaction with Ciprofloxacin.
-History of spasticity (due to the potential for requiring tizanidine treatment), asthma,
chronic bronchitis, emphysema, and other lung diseases (due to potential for requiring
theophylline [or dimethylxanthine] treatment). -Medical, occupational, or family problems
as a result of alcohol or illicit drug use during the past 12 months.
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