Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

NCT03184766 | Completed Phase 1

• 1 other identifier: NL1309
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine).

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Pseudoephedrine AUC0-t for Test vs. Comparator 1.

  The Test and Comparator 1 will be considered similar if for pseudoephedrine, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis: 0-48hrs

• Pseudoephedrine Cmax for Test vs. Comparator 1.

  The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis: 0-48hrs

• Ibuprofen AUC0-t for Test vs. Comparator 2.

  The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis: 0-48hrs

• Ibuprofen Cmax for Test vs. Comparator 2.

  The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:

  PK Analysis: 0-48hrs

Secondary Outcomes (10)

• Ibuprofen AUC0-t for Test vs. Comparator 1.

  PK Analysis: 0-48hrs

• Ibuprofen Cmax for Test vs. Comparator 1.

  PK Analysis: 0-48hrs

• Assessment of how fast the ibuprofen from the Test product starts to be absorbed and how quickly it reaches the therapeutic level.

  PK Analysis: 0-48hrs

• Pharmacokinetic parameters will be assessed as secondary endpoints.

  PK Analysis: 0-48hrs

• Pharmacokinetic parameters will be assessed as secondary endpoints.

  PK Analysis: 0-48hrs

Other Outcomes (7)

• The occurrence of Adverse Events.

  Through study completion - Screening to study follow-up (Approx 8 weeks)

• Change from baseline in oral temperature.

  Through study completion - Screening to study follow-up (Approx 8 weeks)

• Change from baseline in resting heart rate.

  Through study completion - Screening to study follow-up (Approx 8 weeks)

Study Arms (6)

1

EXPERIMENTAL

Treatment Order: Test, Comparator 1, Comparator 2

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

2

EXPERIMENTAL

Treatment Order: Test, Comparator 2, Comparator 1

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

3

EXPERIMENTAL

Treatment Order: Comparator 1, Test, Comparator 2

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

4

EXPERIMENTAL

Treatment Order: Comparator 1, Comparator 2, Test

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

5

EXPERIMENTAL

Treatment Order: Comparator 2, Test, Comparator 1

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

6

EXPERIMENTAL

Treatment Order: Comparator 2, Comparator 1, Test

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules; Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets; Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Interventions

Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules DRUG

2 x 200 mg ibuprofen \& 30 mg pseudoephedrine

1; 2; 3; 4; 5; 6

Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets DRUG

2 x 200 mg ibuprofen \& 30 mg pseudoephedrine

1; 2; 3; 4; 5; 6

Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules DRUG

2 x 200 mg solubilised ibuprofen

1; 2; 3; 4; 5; 6

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, 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.
• 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 ibuprofen, aspirin, other NSAIDs, pseudoephedrine, other sympathomimetic or catecholamine derivative decongestant drugs 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 hypertension or hypertension that is currently treated with antihypertensive medication.
• 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).
• Those with positive screen/test for drugs of abuse and alcohol.
• Those with a positive screen for ibuprofen.
• 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 30 days prior to the first dose of study medication.
• Ingestion of an over-the-counter preparation within 7 days before the first dose of study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen, other NSAIDs or decongestants.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Influenza Vaccines; Ibuprofen; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Robert Adams, MBBS

  Simbec Research

  PRINCIPAL INVESTIGATOR

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: June 14, 2017
• Study Start: August 10, 2016
• Primary Completion: January 30, 2017
• Study Completion: January 30, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share