NCT02956525

Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions

Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 200 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Detailed description

A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement. After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions. To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Dexibuprofen	Dexibuprofen 200 mg

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-11-07
• Last updated: 2023-02-09

Locations

1 site across 1 country: Brazil