Conditions: Gastroduodenal Ulceration
Keywords: Healthy volunteer comparison of incidence of treatment groups.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: yes

Brief summary:
This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Detailed description:
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Arms:
arm 1: Investigational product, PL2200 arm 2: Active comparator, 325 mg aspirin tablets

Interventions: intervention 1: PL2200 intervention 2: Aspirin tablets
Intervention descriptions: intervention 1: PL2200, containing 325 mg aspirin active ingredient intervention 2: 325 mg aspirin tablets (USP)

Protocol document: