Clinical trial NCT02184247: Bioavailability of Two Sustained-release Theophylline Products in Healthy Males
Official title: A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg theophylline anhydrous (sustained-release product) by comparing the rate and extent of absorption of theophylline based on both single and multiple-dose profiles.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking male subjects between 18 and 45 years of age
* Body weight within 10% of the ideal weight according to the Body Mass Index (BMI)
* Normal health based on medical history and findings within the range of clinical acceptability, in respect of the physical examination (including electrocardiogram and vital signs) and special investigations
* Ability to comprehend and willingness to sign both statements of informed consent (for screening and study-specific procedures)

Exclusion Criteria:

* History of serious systemic or organ disease
* A major illness during the 3 months before commencement of the study-related procedures
* Significant physical or organ abnormality
* History of hypersensitivity to theophylline or other xanthine derivatives
* Use of any medication within 2 weeks before the first administration of study medication
* Participation in another study with an experimental drug within 8 weeks before the first administration of study medication
* Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system (for example chloramphenicol, which may cause bone marrow suppression)
* Donation of blood during the 8 weeks before the first administration of study medication
* History of, or current compulsive alcohol abuse (\> 10 drinks per week), of regular exposure to other substance of abuse
* Positive testing for HIV and hepatitis B antigens within the previous 3 months

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
timeFrame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs at steady state (AUDss)
timeFrame: up to 12 hours after last administration of study drug
measure: Percent peak-to-trough fluctuation (%PTF)
timeFrame: up to 12 hours after last administration of study drug
Secondary outcomes:
measure: Time to maximum concentration (Tmax)
timeFrame: up to 36 hours after first drug administration
measure: Apparent terminal half-life (t1/2.z)
timeFrame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs [AUD(0-tlast)], also indicated by AUD, where tlast is the time of the last quantifiable concentration
timeFrame: up to 36 hours after first drug administration
measure: Ratio of Cmax and AUDC (Cmax/AUDC)
timeFrame: up to 36 hours after first drug administration
measure: Total mean time in the system (MTvsys)
timeFrame: up to 36 hours after first drug administration
measure: Maximum concentration at steady state (Cmax,ss)
timeFrame: up to 12 hours after last administration of study drug
measure: Minimum concentration at steady state (Cmin,ss)
timeFrame: up to 12 hours after last administration of study drug
measure: Plateau time (T75%Cmax)
timeFrame: up to 12 hours after last administration of study drug
Other outcomes:
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