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Bioavailability of Two Sustained-release Theophylline Products in Healthy Males

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: anhydrous theophylline, 350 mg (Drug); anhydrous theophylline, 300 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum concentration (Cmax)

Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)

Area under the plasma concentration versus time data pairs at steady state (AUDss)

Percent peak-to-trough fluctuation (%PTF)

Secondary outcome:

Time to maximum concentration (Tmax)

Apparent terminal half-life (t1/2.z)

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

Ratio of Cmax and AUDC (Cmax/AUDC)

Total mean time in the system (MTvsys)

Maximum concentration at steady state (Cmax,ss)

Minimum concentration at steady state (Cmin,ss)

Plateau time (T75%Cmax)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: April 1998
Last updated: July 8, 2014

Page last updated: August 23, 2015

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