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Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions
Sponsor: Apsen Farmaceutica S.A.
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
Conditions
Interventions
Dexibuprofen
Dexibuprofen 300mg
Locations (1)
Azidus laboratories Ltd.
Valinhos, São Paulo, Brazil