check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
17944
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
Trial purpose
To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg combination product) under fed conditions in healthy adult subjects.
To assess the safety and tolerability of the investigational products in terms of adverse events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical examination, clinical and laboratory testing).
To assess the safety and tolerability of the investigational products in terms of adverse events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical examination, clinical and laboratory testing).
Key Participants Requirements
Sex
AllAge
18 - 55 YearsTrial summary
Enrollment Goal
60Trial Dates
March 2018 - April 2018Phase
Phase 1Could I Receive a placebo
NoProducts
Aleve PM (BAY98-7111)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | ICON Development Solutions, LLC | San Antonio, 78219, United States |
Primary Outcome
- AUCArea under the concentration vs. time curve from zero to infinity after single (first) dosedate_rangeTime Frame:Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
- AUC(0-tlast)Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal ruledate_rangeTime Frame:Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
- CmaxMaximum observed drug concentration, directly observed from analytical datadate_rangeTime Frame:Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Secondary Outcome
- Number of adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 5 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2