Bioavailability of Two Sustained-release Theophylline Products in Healthy Males

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Theophylline

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