Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182960
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Pharmacokinetics (relative bioavailability), safety and tolerability

Condition or disease Intervention/treatment Phase
Healthy Drug: Ibuprofen syrup Drug: Brufen syrup Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Two Way Cross Over Study to Relative Bioavailability of Ibuprofen Enantiomers After Single p.o. Administration of 200 mg Syrup (T) Compared With 200 mg Standard Brufen Sirup (R)
Study Start Date : September 1998
Actual Primary Completion Date : October 1998

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen Drug: Ibuprofen syrup
Active Comparator: Brufen Drug: Brufen syrup



Primary Outcome Measures :
  1. Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞) [ Time Frame: Up to 12 hours after each administration ]
  2. Maximum drug plasma concentration (Cmax) [ Time Frame: Up to 12 hours after each administration ]

Secondary Outcome Measures :
  1. Time to reach the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Up to 12 hours after each administration ]
  2. Apparent terminal rate constant (λz) [ Time Frame: Up to 12 hours after each administration ]
  3. Apparent terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 12 hours after each administration ]
  4. Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last)) [ Time Frame: Up to 12 hours after each administration ]
  5. Mean residence time, total (MRTtot) [ Time Frame: Up to 12 hours after each administration ]
  6. Total plasma clearance divided by the systemic availability factor (CL/f) [ Time Frame: Up to 12 hours after each administration ]
  7. Volume of distribution during the terminal phase λz, divided by f (Vz/f) [ Time Frame: Up to 12 hours after each administration ]
  8. Number of adverse events [ Time Frame: Up to 8 days after last drug administration ]
  9. Change from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, 8 days after last drug administration ]
  10. Change in vital functions (blood pressure and puls rate) [ Time Frame: Baseline, up to 8 days after last drug administration ]
  11. Change from baseline in standard laboratory evaluation [ Time Frame: Baseline, 8 days after last drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)
  • Written informed consent

Exclusion Criteria:

  • Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of a drug with a long half-life (>=24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
  • Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to the start of the study
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse
  • Drug abuse
  • Blood donation (>100 ml) within four weeks prior to administration
  • Other disease or abnormality of clinical relevance
  • Excessive physical activities within two weeks prior to administration or during the trial

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182960    
Other Study ID Numbers: 1024.3
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action