Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

Exclusion Criteria

• •Disorders known to be associated with abnormal GI motility
• •History of surgery that alters the normal function of the gastrointestinal tract
• •Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS)
• •Active gastric or duodenal ulcers or history of severe ulcers
• •Diabetes mellitus (type 1 or type 2)
• •Congestive Heart Failure
• •History of Human Immunodeficiency Virus (HIV), Hepatitis B or C
• •Use of concurrent therapy(ies) for symptoms of lactose intolerance
• •Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1
• •History of ethanol abuse in the past 12 months
• •History of drug abuse within 12 months
• •History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area)
• •Use of any investigational drug or participation in any investigational study within 30 days prior to Screening