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Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT01170637
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : August 31, 2018
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 26, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE July 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable time point) [ Time Frame: 1 month ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (*=infinity) [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.
Official Title  ICMJE Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial).
Brief Summary The objective of the current study is to demonstrate bioequivalence of a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg following orally administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ibuprofen
    200 mg oral administration (RhinAdvil(R))
  • Drug: Ibuprofen
    200 mg oral administration (BI product)
  • Drug: Pseudoephedrine-HCl
    30 mg oral administration (BI product)
  • Drug: Pseudoephedrine-HCl
    30 mg oral administration (RhinAdvil(R))
Study Arms  ICMJE
  • Active Comparator: Ibuprofen 200 mg
    Oral administration as a fixed dose combination tablet (RhinAdvil(R))
    Intervention: Drug: Ibuprofen
  • Active Comparator: Pseudoephedrine-HCl 30 mg
    Oral administration as a fixed dose combination tablet (RhinAdvil(R))
    Intervention: Drug: Pseudoephedrine-HCl
  • Active Comparator: Ibuprofen 200 mg BI
    Oral administration as a fixed dose combination tablet (BI product)
    Intervention: Drug: Ibuprofen
  • Active Comparator: Pseudoephedrine-HCl 30 mg BI
    Oral administration as a fixed dose combination tablet (BI product)
    Intervention: Drug: Pseudoephedrine-HCl
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: October 18, 2010)
47
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
48
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Healthy males and females according to the following criteria:

    Based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

  2. Age 21 to 50 years
  3. BMI 18.5 to 29.9 kg/m2
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Any relevant Gastrointestinal (e.g. ulcera, hernia, bleedings and spasm), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Any relevant surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. Chronic or relevant acute infections
  8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
  9. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to first drug administration
  10. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
  11. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
  12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  13. Inability to refrain from smoking on trial days as judged by the investigator
  14. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration of the trial drug in this study)
  17. Excessive physical activities within 1 week prior to randomisation or during the trial
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. Inability to comply with dietary regimen of the study centre
  20. Unwilling to avoid excessive sunlight exposure
  21. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater)
  22. A marked baseline prolongation of the QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  23. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170637
Other Study ID Numbers  ICMJE 1024.7
2010-019052-45 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, 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 August 2018

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