Healthy
Conditions
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.
Interventions
DRUGanhydrous theophylline, 350 mg
DRUGanhydrous theophylline, 300 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | up to 36 hours after first drug administration |
| Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC) | up to 36 hours after first drug administration |
| Area under the plasma concentration versus time data pairs at steady state (AUDss) | up to 12 hours after last administration of study drug |
| Percent peak-to-trough fluctuation (%PTF) | up to 12 hours after last administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Total mean time in the system (MTvsys) | up to 36 hours after first drug administration |
| Maximum concentration at steady state (Cmax,ss) | up to 12 hours after last administration of study drug |
| Time to maximum concentration (Tmax) | up to 36 hours after first drug administration |
| Plateau time (T75%Cmax) | up to 12 hours after last administration of study drug |
| Minimum concentration at steady state (Cmin,ss) | up to 12 hours after last administration of study drug |
| Apparent terminal half-life (t1/2.z) | up to 36 hours after first drug administration |
| 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 | up to 36 hours after first drug administration |
| Ratio of Cmax and AUDC (Cmax/AUDC) | up to 36 hours after first drug administration |
Outcome results
None listed