Gastrointestinal Disorders

We have conducted over 100 Phase l/ll PK or PD studies involving drugs acting locally in the gastrointestinal tract or systemically.

Gastrointestinal Disorders

Additional resources

Our Experience

  • Over 100 Phase I/II PK or PD studies involving drugs acting locally in the gastrointestinal (GI) tract or systemically:
    • Antacids and mucosal protective agents
    • Gastric antisecretory (anti-H2 and PPIs)
    • GI motility (cisapride and cisapride-like)
    • Dissolution of gallstones
    • Inflammatory bowel disease treatment
  • Pharmacokinetic assessments on locally acting drugs despite the low bioavailability of the drug
  • Assessment of GI pharmacodynamics response using:
    • Measurement of intra-gastric pH
    • Rectal biopsy
    • Visceral pain model using the barostat method to assess rectal distension and rectal sensory threshold
    • Endoscopy
    • Colonoscopy
  • Full clinical pharmacology program for a new prokinetic agent from FIH to DDI; and renal impairment

Cases Studies

Patient Access

  • 250+ patients with ileostomy
  • 150+ patients with ulcerative colitis
  • 200+ patients with Crohn’s disease
  • 100+ patients with irritable bowel syndrome
  • 1000+ patients with gastroesophageal reflux disease (GERD)
  • Searchable database to qualify Inclusion/Exclusion criteria for pre-existing conditions, demographics, medication use and BMI

Clinical Expertise

  • Medical expertise and the support of a gastroenterologist with 20+ years of experience in Phase I/II clinical research
  • Administration of different types of formulations (oral,suppository, rectal gel, enema, gastro-retentive capsule, etc.)
  • GI condition assessment techniques such as endoscopy, colonoscopy, radiology and X-ray imaging with barium, barostat, microbial and intragastric pH measurement
  • Experience with swallowability and palatability assessment