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

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)

Pharmacokinetics (relative bioavailability), safety and tolerability

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ibuprofen syrup; Drug: Brufen syrup

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen	Drug: Ibuprofen syrup
Active Comparator: Brufen	Drug: Brufen syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)	Up to 12 hours after each administration
Maximum drug plasma concentration (Cmax)	Up to 12 hours after each administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Primary Completion (Actual): October 1, 1998

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 1024.3