Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study

NCT03167541 | Completed Phase 1 Results

• 1 other identifier: RB9-UK-1514
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands in order to support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under Plasma Concentration-time at Time t (AUC0-t)

  AUC0-t defines Area under the plasma concentration-time curve (AUC) from administration to the last quantifiable concentration at time t.

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

• Maximum Plasma Concentration (Cmax)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

Secondary Outcomes (7)

• Elimination Rate Constant (Kel)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

• Area Under the Plasma Concentration Curve From Administration to Infinity (AUC0-inf)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

• Residual Area (AUC%Extrap)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

• Time Until Cmax is First Achieved (Tmax)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

• Plasma Concentration (Elimination) Half-life (T1/2)

  Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose

Study Arms (2)

1

EXPERIMENTAL

Treatment Order: Test, Reference

Drug: Test; Drug: Reference

2

EXPERIMENTAL

Treatment Order: Reference, Test

Drug: Test; Drug: Reference

Interventions

Test DRUG

RB naproxen sodium tablets (2x220mg)

1; 2

Reference DRUG

Aleve naproxen sodium tablets (2x220mg)

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects who have given written informed consent.
• Age: ≥ 18 years ≤ 50 years.
• Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
• Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
• Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
• Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
• Male subject willing to use an effective method of contraception unless anatomically sterile or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.

You may not qualify if:

• Pregnant or lactating females.
• Intention to become pregnant during the course of the study
• Lack of safe contraception.
• A history and/or presence of significant disease of any body system, including psychiatric disorders.
• Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
• A history of allergy or intolerance related to treatment with naproxen or other NSAIDs, or the excipients of the formulations.
• A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
• A history of frequent dyspepsia, e.g. heartburn or indigestion.
• A history of migraine.
• Current smokers and ex-smokers who have smoked or used nicotine replacement products during the previous 6 months prior to first dosing.
• A history of substance abuse (including alcohol).
• High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc; total caffeine intake per day above 300 mg \[1 cup of coffee equates to approximately 50 mg caffeine\]).
• Those with positive screen/test for drugs of abuse and alcohol.
• Ingestion of a prescribed drug at any time in the 14 days before the first dose of study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers (drug, food or herb) 30 days prior to the first dose of study medication (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
• Ingestion of an over-the-counter (OTC) preparation within 7 days before the first dose of study medication, including herbal medications, vitamin/fish oil supplements, naproxen and other NSAIDs.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Simbec Research: collaborator

Results Point of Contact

• Title: Clinical Research Director, Clinical Research
• Organization: Reckitt Benckiser Healthcare (UK) Ltd

clinicalrequests@rb.com

+44 (0) 1482326151

Study Officials

• Robert Adams, MBBS

  Simbec Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: October 12, 2016
• Primary Completion: December 2, 2016
• Study Completion: December 2, 2016
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share