NCT02902302

Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet

Bioequivalence Study of a New Formulation of Ibuprofen 400 mg/10 mL Oral Suspension vs. the Reference Product MOMENTACT 400 mg Film-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 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg film-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 400 mg/10 mL oral suspension
DRUG	MOMENT 400 mg coated tablet

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2016-09-15
• Last updated: 2016-09-15

Locations

1 site across 1 country: Switzerland