A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments

Pain Clinical Trial

Official title:

A Single-Dose, Randomised, Crossover Bioequivalence Study to Compare the Rate and Extent of Absorption of a Test Formulation of Ibuprofen Fast Melt Orodispersible Tablet Versus Two Reference Formulations in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316978
• Other study ID #: IBUPAI1001
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2011
• Last updated: July 6, 2012
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.

Description:

The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data [R-enantiomer, S-enantiomer and total (sum of both enantiomers)]. The rate and extent of absorption of the formulations will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female subjects (equal numbers of males and females)

• Volunteers aged of at least 18 years but not older than 55 years

• Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight >50 kg

• Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.

• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance

• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)

• Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study

• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

• Seated pulse rate below 45 bpm or higher than 90 bpm at screening

• Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening

• Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each)

• Presence of any tongue piercings

• Presence of braces

• Females who are pregnant or are lactating

• Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study

• Females who are pregnant according to a positive serum pregnancy test

• Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ibuprofen
A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout between visits
• Ibuprofen
A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits
• Ibuprofen
A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits

Locations

Country	Name	City	State
Canada	Algorithme Pharma Inc.	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration	Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)	During 12 hours post-dose	No
Primary	Bioavailability [AUC(0-t)]	Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL).	During 12 hours post-dose	No
Secondary	Bioavailability Extrapolated to Infinity [AUC (0-8)]	Bioavailability Extrapolated to Infinity [AUC (0-8)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-8) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-8).	12 hours post-dose	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During 12 hours post-dose	No
Secondary	Terminal Elimination Rate Constant	The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose	During 12 hours post-dose	No
Secondary	Terminal Phase Plasma Half-Life	Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.	During 12 hours post-dose	No