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

NCT02182960 | Completed Phase 1

• 1 other identifier: 1024.3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pharmacokinetics (relative bioavailability), safety and tolerability

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Drug: Ibuprofen syrup

Brufen

ACTIVE COMPARATOR

Drug: Brufen syrup

Interventions

Ibuprofen syrup DRUG

Ibuprofen

Brufen syrup DRUG

Brufen

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 1998
• Primary Completion: October 1, 1998
• Last Updated: August 31, 2018

Record last verified: 2018-08