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COMPLETED
NCT02956512
PHASE1

Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions

Sponsor: Apsen Farmaceutica S.A.

View on ClinicalTrials.gov

Summary

Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Official title: Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 300 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2019-03-18

Completion Date

2019-09-06

Last Updated

2026-09-08

Healthy Volunteers

Yes

Interventions

DRUG

Dexibuprofen

Dexibuprofen 300mg

Locations (1)

Azidus laboratories Ltd.

Valinhos, São Paulo, Brazil