Clinical Trials/NCT02452450

NCT02452450

Completed

Phase 1

Ibuprofen and Paracetamol Pharmacokinetic Study

Reckitt Benckiser Healthcare (UK) Limited0 sites43 target enrollmentJanuary 2014

ConditionsHealthy Volunteer Study

InterventionsIbuprofen Lysine Ibuprofen Sodium Ibuprofen Liquid Capsules Ibuprofen Acid Paracetamol

DrugsIbuprofen Acid Ibuprofen Lysine Ibuprofen Sodium Ibuprofen Liquid Capsules Paracetamol

Overview

Phase: Phase 1
Intervention: Ibuprofen Lysine
Conditions: Healthy Volunteer Study
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Enrollment: 43
Primary Endpoint: Time to the maximum concentration (Cmax) of the reference Ibuprofen
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

October 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: \> 18 to \< 50 years.
•Sex: Male and female subjects are eligible for entry.
•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
•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.
•Status: Healthy volunteers with a body mass index of \>18 and \<30 kg/m
•Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis.
•Subjects who have given written informed consent

Exclusion Criteria

•Pregnant or lactating female subjects.
•A history of significant disease of any body-system.
•Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
•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.
•A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
•A history of frequent dyspepsia, e.g., heartburn or indigestion.
•A history of migraine.
•A history of psychotic illness, attempted suicide or parasuicide.
•Current smokers and ex-smokers who have smoked within 6 months.
•A history of drug abuse (including alcohol).

Arms & Interventions

Ibuprofen lysine

Intervention: Ibuprofen Lysine

Ibuprofen sodium

Intervention: Ibuprofen Sodium

Ibuprofen liquid capsules

Intervention: Ibuprofen Liquid Capsules

Ibuprofen acid

Intervention: Ibuprofen Acid

Paracetamol

Intervention: Paracetamol

Outcomes

Primary Outcomes

Time to the maximum concentration (Cmax) of the reference Ibuprofen

Time Frame: 0-4hr

Time to the first extrapolated non-zero concentration (Tlag)

Time Frame: 0-4hr

Time to the maximum concentration (Tmax)

Time Frame: 0-4hr

Secondary Outcomes

Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol(0-4hr)
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)
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)
Partial area under the curve (AUCs) at each nominal blood sampling time-point(0-4hr)
The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef)(0-4hr)
The plasma concentration at each planned nominal time-point (Cn)(0-4hr)
The maximum plasma concentration (Cmax)(0-4hr)