Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Fever
- Pain Acute
- Pain, Back
- Pain, Head
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: open-label, single-dose, randomized, two-period, two-treatment, twosequence, crossover, comparative bioavailability study.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the...
Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).
Tracking Information
- NCT #
- NCT03429738
- Collaborators
- Pharma Medica Research, Inc.
- Investigators
- Study Director: Latifa Yamlahi, MD Pharma Medica Research, Inc.
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