Ensayos clínicos

Inclusion Criteria

• Males and non-pregnant, non-breastfeeding females
• Age 18-65 years
• No functional GI disorders on the short Bowel Disease Questionnaire (BDQ)
• A BMI greater than 22.0

Exclusion Criteria

• 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
• Any medication that alters GI transit and unable to withdraw from them 48 hours prior to study entry, 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, and COX 2 inhibitors 
    • Tylenol is permitted
  • GABAergic agents and benzodiazepines
    • Concomitant medications will be reviewed on a case by case basis by the study physicians
• 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
• 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