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To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet

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ClinicalTrials.gov Identifier: NCT02629354
Recruitment Status : Completed
First Posted : December 14, 2015
Results First Posted : March 16, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE December 10, 2015
First Posted Date  ICMJE December 14, 2015
Results First Submitted Date  ICMJE January 27, 2017
Results First Posted Date  ICMJE March 16, 2017
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the maximum observed concentration (Cmax) of S-ibuprofen in plasma obtained directly from the concentration-time data.
  • Cmax of R-ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the Cmax of R-ibuprofen in plasma obtained directly from the concentration-time data.
  • Cmax of Ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the Cmax of ibuprofen in plasma obtained directly from the concentration-time data.
  • Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t) [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).
  • AUC0-t of R-ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).
  • AUC0-t of Ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • Maximum observed plasma concentration (Cmax of R-ibuprofen) obtained directly from the concentration-time data [ Time Frame: 0-24 hours after dosing ]
  • Maximum observed plasma concentration (Cmax of S-ibuprofen) obtained directly from the concentration-time data [ Time Frame: 0-24 hours after dosing ]
  • Area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t) [ Time Frame: 0-24 hours after dosing ]
  • Area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t) [ Time Frame: 0-24 hours after dosing ]
  • Area under the plasma concentration of Ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t) [ Time Frame: 0-24 hours after dosing ]
  • Maximum plasma concentration (Cmax of Ibuprofen) calculated from the sum of Cmax of R-ibuprofen and Cmax of S-ibuprofen directly measured from plasma concentration. [ Time Frame: 0-24 hours after dosing ]
Change History Complete list of historical versions of study NCT02629354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).
  • AUC0-INF of R-ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).
  • AUC0-INF of Ibuprofen [ Time Frame: Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose ]
    This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • Area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF) [ Time Frame: 0-24 hours after dosing ]
  • Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) [ Time Frame: 0-24 hours after dosing ]
  • Area under the plasma concentration of Ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF) [ Time Frame: 0-24 hours after dosing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
Official Title  ICMJE A Single Center, Single Dose, Open Label, Randomized, Two Period, Two Sequence Crossover Study to Evaluate the Relative Bioavailibility of Ibuprofen From a Fixed-dose Combination Tablet Containing Ibuprofen 400 mg and Caffeine 100 mg and a Tablet of Ibuprofen 400 mg in at Least 30 Healthy Males and Females Under Fed Conditions
Brief Summary The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ibuprofen
  • Drug: Caffeine
Study Arms  ICMJE
  • Experimental: Ibuprofen and Caffeine
    Interventions:
    • Drug: Ibuprofen
    • Drug: Caffeine
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy males and females, 18 to 50 years (inclusive) at time of screening.
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
  • Body mass not less than 50 kg.
  • Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be irrelevant for the purpose of the study.
  • Non-smokers and mild or moderate smokers (<= 10 cigarettes or pipes per day). Further inclusion criteria apply

Exclusion criteria:

  • Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
  • Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females. One unit is equal to beer [200 mL/10 ounces], wine [100 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
  • Regular exposure to substances of abuse (other than alcohol) within the past year.
  • Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the PI. In this study the concomitant use of hormonal contraceptives is allowed.
  • Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for anti-bodies or insulin), whichever is the longer) before administration of IMP in this study, at the discretion of the PI.
  • Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
  • History of hypersensitivity or allergy (angioedema or urticaria) to the IMP or its excipients or any related medication (Aspirin or any other NSAID).
  • Diagnosis of hypotension made during the screening period.
  • Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
  • Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
  • Renal impairment.
  • Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the PI.

Further exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02629354
Other Study ID Numbers  ICMJE 1335.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP