NCT03396250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

January 5, 2018

Last Update Submit

March 19, 2019

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

  • AUC

    Area under the concentration vs. time curve from zero to infinity after single (first) dose

    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

    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

    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 Outcomes (1)

  • Number of adverse events as a measure of safety and tolerability

    Up to 5 weeks

Study Arms (2)

Test product + Reference product

EXPERIMENTAL

Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.

Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsulesDrug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)

Reference product + Test product

EXPERIMENTAL

Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.

Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsulesDrug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)

Interventions

Naproxen sodium and diphenhydramine hydrochloride soft capsulesDRUG

Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)

Reference product + Test productTest product + Reference product
Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)DRUG

Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)

Reference product + Test productTest product + Reference product

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult men or women
  • Age 18 to 55 years inclusive;
  • Body mass index 18.5 to 30.0 kg/m2 inclusive

You may not qualify if:

  • History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;
  • Females who are pregnant or lactating;
  • Vegetarian or restricted diet (e.g., gluten-free);
  • Any active disease, acute or chronic;
  • Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter \[OTC\] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;
  • Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;
  • Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;
  • Positive test for hepatitis B surface antigen (HBsAg) test;
  • Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;
  • In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;
  • Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;
  • More than moderate alcohol consumption (\>40 g of alcohol regularly per day);
  • Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.
  • Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;
  • Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Development Solutions, LLC

San Antonio, Texas, 78219, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 10, 2018

Study Start

February 12, 2018

Primary Completion

March 26, 2018

Study Completion

March 29, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

US(1)