Ibuprofen and Paracetamol Pharmacokinetic Study

Healthy Volunteer Study Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452450
• Other study ID #: NL1307
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2015
• Last updated: May 22, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Ibuprofen Acid

• Ibuprofen Lysine

• Ibuprofen Sodium

• Ibuprofen Liquid Capsules

• Paracetamol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited	Simbec Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the maximum concentration (Cmax) of the reference Ibuprofen		0-4hr	No
Primary	Time to the first extrapolated non-zero concentration (Tlag)		0-4hr	No
Primary	Time to the maximum concentration (Tmax)		0-4hr	No
Secondary	Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol		0-4hr	No
Secondary	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	No
Secondary	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	No
Secondary	Partial area under the curve (AUCs) at each nominal blood sampling time-point		0-4hr	No
Secondary	The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef)		0-4hr	No
Secondary	The plasma concentration at each planned nominal time-point (Cn)		0-4hr	No
Secondary	The maximum plasma concentration (Cmax)		0-4hr	No