Status:
COMPLETED
Bioavailability of Two Sustained-release Theophylline Products in Healthy Males
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 (sus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02184247
Start Date
April 1 1998
Last Update
July 9 2014
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