Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

Reckitt Benckiser

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03184766

NL1309

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subjects who have given written informed consent.
2. Age: ≥ 18 years ≤ 50 years.
3. Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
4. Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
5. 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.
6. Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
7. 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.

Exclusion criteria

1. Pregnant or lactating females.
2. A history and/or presence of significant disease of any body system, including psychiatric disorders.
3. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
4. 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.
5. A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
6. A history of hypertension or hypertension that is currently treated with antihypertensive medication.
7. A history of frequent dyspepsia, e.g. heartburn or indigestion.
8. A history of migraine.
9. Current smokers and ex-smokers who have smoked or used nicotine replacement products during the previous 6 months prior to first dosing.
10. A history of substance abuse (including alcohol).
11. High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg).
12. Those with positive screen/test for drugs of abuse and alcohol.
13. Those with a positive screen for ibuprofen.
14. 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.
15. 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.
16. Donation of blood in quantity > 400 ml e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication
17. Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
18. Topical use of ibuprofen within 7 days before the first dose of study medication.
19. Those previously randomised into this study.
20. Those who are an employee at the study site.
21. Those who are a partner or first degree relative of the Investigator.
22. Those who have participated in a clinical trial in the 12 weeks prior to the first dose of study medication.
23. Those unable in the opinion of the Investigator to comply fully with the study requirements.
24. Those who have consumed grapefruit or grapefruit juice, pummelo or Seville oranges in the 7 days prior to randomisation.
25. Those who are unwilling to consume gelatine of animal origin.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 6 patient groups

1

Experimental group

Description:

Treatment Order: Test, Comparator 1, Comparator 2

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

2

Experimental group

Description:

Treatment Order: Test, Comparator 2, Comparator 1

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

3

Experimental group

Description:

Treatment Order: Comparator 1, Test, Comparator 2

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

4

Experimental group

Description:

Treatment Order: Comparator 1, Comparator 2, Test

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

5

Experimental group

Description:

Treatment Order: Comparator 2, Test, Comparator 1

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

6

Experimental group

Description:

Treatment Order: Comparator 2, Comparator 1, Test

Treatment:

Drug: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

Drug: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

Drug: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets