At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 Healthy Male and Female Subjects (Open-label, Randomized, Laboratory Blind, Single Dose, Two-way Crossover, Phase I Trial).
In Brief
A Phase 1 clinical trial evaluating Ibuprofen and Pseudoephedrine-HCl for Healthy Volunteers. Completed, enrolled 56 participants across 1 site.
Detailed Summary
Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to the analytes, ibuprofen and pseudoephedrine. Secondary objective To assess the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to R- and S-ibuprofen (enantiomers of ibuprofen).
Study Details
Timeline
Interventions
Fixed dose combination
Fixed dose combination