BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

• Assessment of Residual Stool - Cecum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Stool - Ascending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Stool - Transverse Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Stool - Descending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Stool - Sigmoid Colon/Rectum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Fluid - Cecum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Fluid - Ascending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Fluid - Transverse Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Fluid - Descending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
• Assessment of Residual Fluid - Sigmoid Colon/Rectum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
• Subject Symptom Scores [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).
• Mean Change in Serum Chemistry (mg/dL) [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
• Mean Change in Serum Chemistry (mEq/L) [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.

To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

• Drug: BLI800
  Solution for oral administration prior to colonoscopy
• Drug: Polyethylene glycol 3350 based bowel preparation
  Solution for oral administration prior to colonoscopy

• Active Comparator: Polyethylene glycol 3350 based bowel preparation
  Polyethylene glycol 3350 based bowel preparation
  Intervention: Drug: Polyethylene glycol 3350 based bowel preparation
• Experimental: BLI800
  BLI800
  Intervention: Drug: BLI800

Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous gastrointestinal surgeries.
3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.