NCT02902289

Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet

Bioequivalence Study of a New Formulation of Ibuprofen 200 mg/5 mL Oral Suspension vs. the Reference Product MOMENT 200 mg Coated Tablet in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated tablet, when administered under fasting conditions as single oral dose to healthy male and female volunteers, in two consecutive study periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ibuprofen 200 mg/5 mL oral suspension
DRUG	MOMENT 200 mg coated tablet

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-09-15
• Last updated: 2016-09-15

Locations

1 site across 1 country: Switzerland