Ibuprofen and Paracetamol Pharmacokinetic Study

• Sponsor: Reckitt Benckiser Healthcare (UK) Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02452450
• Collaborator: Simbec Research (Industry)
• Enrollment: 43
• Arms: 5
• Duration (Months): 9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Study	Drug: Ibuprofen Acid; Drug: Ibuprofen Lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen Liquid Capsules; Drug: Paracetamol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibuprofen lysine	Drug: Ibuprofen Lysine
Experimental: Ibuprofen sodium	Drug: Ibuprofen Sodium
Experimental: Ibuprofen liquid capsules	Drug: Ibuprofen Liquid Capsules
Active Comparator: Ibuprofen acid	Drug: Ibuprofen Acid
Active Comparator: Paracetamol	Drug: Paracetamol

Outcome Measures

Primary Outcome Measures

1. Time to the maximum concentration (Cmax) of the reference Ibuprofen [0-4hr]

2. Time to the first extrapolated non-zero concentration (Tlag) [0-4hr]

3. Time to the maximum concentration (Tmax) [0-4hr]

Secondary Outcome Measures

1. Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol [0-4hr]

2. Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol [0-4hr]

3. Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol [0-4hr]

4. Partial area under the curve (AUCs) at each nominal blood sampling time-point [0-4hr]

5. The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef) [0-4hr]

6. The plasma concentration at each planned nominal time-point (Cn) [0-4hr]

7. The maximum plasma concentration (Cmax) [0-4hr]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Reckitt Benckiser Healthcare (UK) Limited
• Simbec Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
• ClinicalTrials.gov Identifier: NCT02452450
• Other Study ID Numbers: NL1307
• First Posted: May 22, 2015
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Acetaminophen; Ibuprofen

Study Results

No Results Posted as of May 27, 2015