HealthyPhase 1NCT02184247
Bioavailability of Two Sustained-release Theophylline Products in Healthy Males
A Phase 1 study testing anhydrous theophylline, 350 mg and anhydrous theophylline, 300 mg in people with Healthy, run by Boehringer Ingelheim.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- anhydrous theophylline, 350 mg and anhydrous theophylline, 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to May 1998
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- anhydrous theophylline, 350 mg, anhydrous theophylline, 300 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anhydrous theophylline, 350 mgDrug
Also called Bronchoretard®
anhydrous theophylline, 300 mgDrug
Also called Theo-Dur®
| Study group | Role | What they receive |
|---|---|---|
| anhydrous theophylline, 350 mg | Experimental | Not described Receives: Drug: anhydrous theophylline, 350 mg |
| anhydrous theophylline, 300 mg | Active comparator | Not described Receives: Drug: anhydrous theophylline, 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
Measured: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs at steady state (AUDss)
Measured: up to 12 hours after last administration of study drug
Percent peak-to-trough fluctuation (%PTF)
Measured: up to 12 hours after last administration of study drug
Secondary outcomes (8)
Time to maximum concentration (Tmax)
Measured: up to 36 hours after first drug administration
Apparent terminal half-life (t1/2.z)
Measured: 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
Measured: up to 36 hours after first drug administration
Ratio of Cmax and AUDC (Cmax/AUDC)
Measured: up to 36 hours after first drug administration
Total mean time in the system (MTvsys)
Measured: up to 36 hours after first drug administration
Maximum concentration at steady state (Cmax,ss)
Measured: up to 12 hours after last administration of study drug
Minimum concentration at steady state (Cmin,ss)
Measured: up to 12 hours after last administration of study drug
Plateau time (T75%Cmax)
Measured: up to 12 hours after last administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startApr 1998
- Primary completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184247
- Sponsor's protocol ID
- 1071.10
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products
- ClinicalTrials.gov ID
- NCT02184247
- Acronym / sponsor ID
- 1071.10
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- May 1998 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anhydrous theophylline, 350 mg | Experimental | Drug: anhydrous theophylline, 350 mg |
| anhydrous theophylline, 300 mg | Active comparator | Drug: anhydrous theophylline, 300 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anhydrous theophylline, 350 mgAlso: Bronchoretard® | Drug | anhydrous theophylline, 350 mg |
| anhydrous theophylline, 300 mgAlso: Theo-Dur® | Drug | anhydrous theophylline, 300 mg |
Primary outcome
Maximum concentration (Cmax)
Time frame: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
Time frame: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs at steady state (AUDss)
Time frame: up to 12 hours after last administration of study drug
Percent peak-to-trough fluctuation (%PTF)
Time frame: up to 12 hours after last administration of study drug
8 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: up to 36 hours after first drug administration
Apparent terminal half-life (t1/2.z)
Time frame: 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
Time frame: up to 36 hours after first drug administration
Ratio of Cmax and AUDC (Cmax/AUDC)
Time frame: up to 36 hours after first drug administration
Total mean time in the system (MTvsys)
Time frame: up to 36 hours after first drug administration
Maximum concentration at steady state (Cmax,ss)
Time frame: up to 12 hours after last administration of study drug
Minimum concentration at steady state (Cmin,ss)
Time frame: up to 12 hours after last administration of study drug
Plateau time (T75%Cmax)
Time frame: up to 12 hours after last administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anhydrous theophylline, 350 mg and anhydrous theophylline, 300 mg in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: up to 36 hours after first drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.