Ibuprofen and Paracetamol Pharmacokinetic Study

Reckitt Benckiser

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Ibuprofen Sodium; Drug: Ibuprofen Acid; Drug: Ibuprofen Liquid Capsules; Drug: Ibuprofen Lysine; Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452450

NL1307

Details and patient eligibility

About

The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.

Enrollment: 43 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: > 18 to < 50 years.
2. Sex: Male and female subjects are eligible for entry.
3. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception, if applicable
4. Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
5. Male subject willing to use an effective method of contraception.
6. Status: Healthy volunteers with a body mass index of >18 and <30 kg/m2.
7. Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis.
8. Subjects who have given written informed consent

Exclusion criteria

1. Pregnant or lactating female subjects.
2. A history of significant disease of any body-system.
3. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
4. A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, or the excipients of the formulations.
5. A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
6. A history of frequent dyspepsia, e.g., heartburn or indigestion.
7. A history of migraine.
8. A history of psychotic illness, attempted suicide or parasuicide.
9. Current smokers and ex-smokers who have smoked within 6 months.
10. A history of drug abuse (including alcohol).
11. High consumption of stimulating drinks
12. Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
13. Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc).
14. Ingestion of an over-the-counter preparation within 7 days before dosing with study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.
15. Donation of blood in quantity in the previous 12 weeks before enrolment into the study
16. Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
17. Topical use of ibuprofen within 7 days before dosing with study medication
18. Those previously randomised into this study.
19. Employee at study site.
20. Partner or first degree relative of the investigator.
21. Those with an ibuprofen level > 10 ng/ml as determined at pre-study screening visit 2 (Part 2 (Pivotal Phase) of the study only).
22. Those who are unwilling to consume gelatin of animal origin (Part 2 (Pivotal Phase) of the study only).
23. Those who have participated in a clinical trial in the previous 12 weeks
24. Those unable in the opinion of the Investigator to comply fully with the study requirements.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 5 patient groups

Ibuprofen lysine

Experimental group

Treatment:

Drug: Ibuprofen Lysine

Ibuprofen sodium

Experimental group

Treatment:

Drug: Ibuprofen Sodium

Ibuprofen liquid capsules

Experimental group

Treatment:

Drug: Ibuprofen Liquid Capsules

Ibuprofen acid

Active Comparator group

Treatment:

Drug: Ibuprofen Acid

Paracetamol

Active Comparator group

Treatment:

Drug: Paracetamol