Bioavailability of Two Sustained-release Theophylline Products in Healthy Males

A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: anhydrous theophylline, 350 mg; Drug: anhydrous theophylline, 300 mg

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anhydrous theophylline, 350 mg	Drug: anhydrous theophylline, 350 mg; Other Names: Bronchoretard®
Active Comparator: anhydrous theophylline, 300 mg	Drug: anhydrous theophylline, 300 mg; Other Names: Theo-Dur®

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
Maximum concentration at steady state (Cmax,ss)	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
Plateau time (T75%Cmax)	up to 12 hours after last administration of study drug

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): May 1, 1998

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Theophylline
• Other Study ID Numbers: 1071.10