ABOUT THIS STUDY
- Males and non-pregnant, non-breastfeeding females
- 18-65 years old
- No functional GI disorders on the short Bowel Disease Questionnaire (BDQ)
- A BMI greater than 22.0
- Structural or metabolic diseases/conditions that affect the gastrointestinal system or
functional gastrointestinal disorders. The short version of the Bowel Disease
Questionnaire (BDQ) will be exclude functional GI disorders. More than three positive
responses will exclude participation.
- Unable to withdraw from the following medications 48 hours prior to study entry:Any
medication that alters GI transit including but not limited to laxatives, magnesium or
aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics,
tricyclic antidepressants, SSRI and newer antidepressants; analgesic drugs including
opiates, NSAID, COX 2 inhibitors (note : Tylenol is permitted); GABAergic agents and
benzodiazepines. Note: Concomitant medications will be reviewed on a case by case
basis by the study physicians.
- Subjects who are considered by the investigator to be alcoholics not in remission or
known substance abusers. Alcohol must be avoided from seven days prior to beginning
the study medication until the completion of the study.
- Subjects who have participated in another clinical study within the past 30 days.
- Clinical evidence (including physical exam and review of the medical history) of
significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal,
hematological, neurological, psychiatric, or other disease that interfere with the
objectives of the study.
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- Rochester, Minnesota