check_circleStudy Completed

Pain

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects

Trial purpose

To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.
To assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.

Key Participants Requirements

Sex

All

Age

18 - 55 Years

Trial summary

Enrollment Goal
36
Trial Dates
February 2018 - March 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
ICON Development Solutions, LLCSan Antonio, 78219, United States

Primary Outcome

  • AUC
    Area under the concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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 rule
    date_rangeTime Frame:
    Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose
  • Cmax
    Maximum observed drug concentration, directly observed from analytical data
    date_rangeTime Frame:
    Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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 tolerability
    date_rangeTime Frame:
    Up to 5 weeks

Trial design

An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2