Conditions: Upper Gastrointestinal Mucosal Damage
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: yes

Brief summary:
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Detailed description:

Arms:
arm 1: PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. arm 2: Immediate release 325mg aspirin

Interventions: intervention 1: acetylsalicylic acid
Intervention descriptions: intervention 1: 325mg once a day for 7 days

Protocol document: