Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.
- Registration Number
- NCT01170637
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to demonstrate bioequivalence of a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg following orally administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibuprofen 200 mg Ibuprofen Oral administration as a fixed dose combination tablet (RhinAdvil(R)) Pseudoephedrine-HCl 30 mg Pseudoephedrine-HCl Oral administration as a fixed dose combination tablet (RhinAdvil(R)) Ibuprofen 200 mg BI Ibuprofen Oral administration as a fixed dose combination tablet (BI product) Pseudoephedrine-HCl 30 mg BI Pseudoephedrine-HCl Oral administration as a fixed dose combination tablet (BI product)
- Primary Outcome Measures
Name Time Method AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable time point) 1 month Cmax (maximum measured concentration of the analyte in plasma) 1 month
- Secondary Outcome Measures
Name Time Method AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (*=infinity) 1 month
Trial Locations
- Locations (1)
1024.7.1 Boehringer Ingelheim Investigational Site
🇩🇪Ingelheim, Germany