Ibuprofen and Paracetamol Pharmacokinetic Study

NCT02452450 | Completed Phase 1

• 1 other identifier: NL1307
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (3)

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

  0-4hr

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

  0-4hr

• Time to the maximum concentration (Tmax)

  0-4hr

Secondary Outcomes (7)

• 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

Study Arms (5)

Ibuprofen lysine

EXPERIMENTAL

Drug: Ibuprofen Lysine

Ibuprofen sodium

EXPERIMENTAL

Drug: Ibuprofen Sodium

Ibuprofen liquid capsules

EXPERIMENTAL

Drug: Ibuprofen Liquid Capsules

Ibuprofen acid

ACTIVE COMPARATOR

Drug: Ibuprofen Acid

Paracetamol

ACTIVE COMPARATOR

Drug: Paracetamol

Interventions

Ibuprofen Acid DRUG

Ibuprofen acid

Ibuprofen Lysine DRUG

Ibuprofen lysine

Ibuprofen Sodium DRUG

Ibuprofen sodium

Ibuprofen Liquid Capsules DRUG

Ibuprofen liquid capsules

Paracetamol DRUG

Paracetamol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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/m2.
• Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis.
• Subjects who have given written informed consent

You may not qualify if:

• 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).
• High consumption of stimulating drinks
• Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
• 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).
• 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.
• Donation of blood in quantity in the previous 12 weeks before enrolment into the study

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Simbec Research: collaborator

Related Publications (1)

• Miles L, Hall J, Jenner B, Addis R, Hutchings S. Predicting rapid analgesic onset of ibuprofen salts compared with ibuprofen acid: Tlag, Tlow, Tmed, and a novel parameter, TCmaxRef. Curr Med Res Opin. 2018 Aug;34(8):1483-1490. doi: 10.1080/03007995.2018.1466697. Epub 2018 Apr 27.

  PMID: 29667449 DERIVED

MeSH Terms

Interventions

Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 22, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05