check_circleStudy Completed
Therapeutic Equivalence
Bayer Identifier:
16135
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Compare Pharmacokinetic (PK) profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride combination
Trial purpose
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
32Trial Dates
January 2012 - March 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Aleve PM (BAY98-7111)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Frontage Laboratories, LLC | Hackensack, 07601, United States |
Primary Outcome
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodiumdate_rangeTime Frame:within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosingenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)date_rangeTime Frame:within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosingenhanced_encryptionNoSafety Issue:
- Cmax(Maximum drug concentration) in plasma of naproxen sodiumdate_rangeTime Frame:within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosingenhanced_encryptionNoSafety Issue:
- Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)date_rangeTime Frame:within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosingenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:up to 6 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
4