Bioavailability of Two Sustained-release Theophylline Products in Healthy Males

NCT02184247 | Completed Phase 1

• 1 other identifier: 1071.10
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Time to maximum concentration (Tmax)

  up to 36 hours after first drug administration

• 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

• Total mean time in the system (MTvsys)

  up to 36 hours after first drug administration

Study Arms (2)

anhydrous theophylline, 350 mg

EXPERIMENTAL

Drug: anhydrous theophylline, 350 mg

anhydrous theophylline, 300 mg

ACTIVE COMPARATOR

Drug: anhydrous theophylline, 300 mg

Interventions

anhydrous theophylline, 350 mg DRUG

Also known as: Bronchoretard®

anhydrous theophylline, 350 mg

anhydrous theophylline, 300 mg DRUG

Also known as: Theo-Dur®

anhydrous theophylline, 300 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Theophylline

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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 8, 2014
• First Posted: July 9, 2014
• Study Start: April 1, 1998
• Primary Completion: May 1, 1998
• Last Updated: July 9, 2014

Record last verified: 2014-07