HealthyPhase 1NCT02273557
Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects
A Phase 1 study testing Asasantin ER (new formulation I - low), Asasantin ER (new formulation III - medium) and Asasantin ER (new formulation II - high) in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin ER (new formulation I - low), Asasantin ER (new formulation III - medium) and Asasantin ER (new formulation II - high)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Feb 2003
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=50 years
- BMI >=18.5 and <=29.9 kg/m2
- Able to communicate well with the investigator and to comply with study requirements
- Laboratory values within a clinically defined reference range
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 20Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial, (< 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (< 3 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
- Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
- Excessive physical activities (< 5 days prior to administration or during the trial)
- Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: Bioavailability of Dipyridamole of Asasantin p.o. (Extended Release 200 mg Dipyridamole/25 mg ASA) in Three Experimental Formulations (Given BID Over 3 Days Each) Relative to the Standard Formulation After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Persantine/25 mg ASA [Asasantin ER] in Healthy Male Subjects. Four-way, Change-over, Randomised, Open
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
- Conditions
- Healthy
- Being tested
- Asasantin ER (new formulation I - low), Asasantin ER (new formulation III - medium), Asasantin ER (new formulation II - high), Asasantin ER (present commercial formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asasantin ER (new formulation I - low)Drug
Asasantin ER (new formulation III - medium)Drug
Asasantin ER (new formulation II - high)Drug
Asasantin ER (present commercial formulation)Drug
| Study group | Role | What they receive |
|---|---|---|
| Asasantin ER (new formulation I - low) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation I - low) |
| Asasantin ER (new formulation III - medium) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation III - medium) |
| Asasantin ER (new formulation II - high) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation II - high) |
| Asasantin ER (present commercial formulation) | Active comparator | Not described Receives: Drug: Asasantin ER (present commercial formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of dipyridamole
represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h
Measured: day 2, day 3
Secondary outcomes (4)
Cmax urine (Maximum measured concentration of the analyte)
Urine collected fraction from 0 -3 hours as surrogate for Cmax
Measured: 0 to 3 hours after drug intake
Cmin urine (Minimum measured concentration of the analyte)
Urine collected fraction from 8 - 10 hours as surrogate for Cmin
Measured: 8- 10 hours after drug intake
%PTF urine (Peak trough fluctuation)
Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval
Measured: Up to 10 hours after drug intake
Number of subjects with adverse events
Measured: up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2003
- Primary completionFeb 2003
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
- 19 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
- NCT02273557
- Sponsor's protocol ID
- 9.163
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Dipyridamole of Asasantin p.o. (Extended Release 200 mg Dipyridamole/25 mg ASA) in Three Experimental Formulations (Given BID Over 3 Days Each) Relative to the Standard Formulation After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Persantine/25 mg ASA [Asasantin ER] in Healthy Male Subjects. Four-way, Change-over, Randomised, Open
- ClinicalTrials.gov ID
- NCT02273557
- Acronym / sponsor ID
- 9.163
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Feb 2003 (actual)
- First posted
- 24 Oct 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.
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asasantin ER (new formulation I - low) | Experimental | Drug: Asasantin ER (new formulation I - low) |
| Asasantin ER (new formulation III - medium) | Experimental | Drug: Asasantin ER (new formulation III - medium) |
| Asasantin ER (new formulation II - high) | Experimental | Drug: Asasantin ER (new formulation II - high) |
| Asasantin ER (present commercial formulation) | Active comparator | Drug: Asasantin ER (present commercial formulation) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=50 years
- BMI >=18.5 and <=29.9 kg/m2
- Able to communicate well with the investigator and to comply with study requirements
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Asasantin ER (new formulation I - low) | Drug | Asasantin ER (new formulation I - low) |
| Asasantin ER (new formulation III - medium) | Drug | Asasantin ER (new formulation III - medium) |
| Asasantin ER (new formulation II - high) | Drug | Asasantin ER (new formulation II - high) |
| Asasantin ER (present commercial formulation) | Drug | Asasantin ER (present commercial formulation) |
Primary outcome
Urinary excretion of dipyridamole
Time frame: day 2, day 3
represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h
4 secondary outcomes
Cmax urine (Maximum measured concentration of the analyte)
Time frame: 0 to 3 hours after drug intake
Cmin urine (Minimum measured concentration of the analyte)
Time frame: 8- 10 hours after drug intake
%PTF urine (Peak trough fluctuation)
Time frame: Up to 10 hours after drug intake
Number of subjects with adverse events
Time frame: up to 23 days
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 24 Oct 2014.
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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 Asasantin ER (new formulation I - low), Asasantin ER (new formulation III - medium) and Asasantin ER (new formulation II - high) 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 6 inclusion and 20 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 24 Oct 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?
Urinary excretion of dipyridamole (time frame: day 2, day 3). 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 24 Oct 2014.