HealthyPhase 1NCT02273544
Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects
A Phase 1 study testing Asasantin ER (new formulation - low), Asasantin ER (new formulation - medium) and Asasantin ER (new formulation - 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 b.i.d. treatment Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin ER (new formulation - low), Asasantin ER (new formulation - medium) and Asasantin ER (new formulation - high)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Oct 2002
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Female subjects are not lactating. Females must use adequate contraception (adequate contraception e.g. sterilization, IUP, oral contraceptives) prior to administration of study medication, during the study until after release from the study. Women must have negative blood pregnancy tests
- Age >= 18 and <= 60 years
- BMI >=18.5 and <=29.9 kg/m2 (see abbreviations for formula)
- 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 28Show fewer
- History of allergy/hypersensitivity (including drug allergy) which were 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 (< 1 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
- Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug
- 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
- For Female Subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, Intrauterine Pessary (IUP), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
- During the interval between screening and start of drug administration tobacco and caffeine are restricted to avoid withdrawal when starting medication. As no relevant influence on Pharmacokinetic parameters is known moderate tobacco and caffeine consumption are allowed to facilitate trial participation (up to 10 cigarettes or 3 cigars or 3 pipes/day, and/or up to three cups of coffee respectively). Ovarian hormone substitution and oral contraception are allowed to be continued during the study
About this study
Official title: Bioavailability of Dipyridamole After Asasantin (Extended Release 200mg Dipyridamole/25mg ASA) in 3 Experimental Formulations (Given b.i.d. Over 3 or 5 Days, Respectively) Relative to the Standard Formulation in 16 Healthy Female and Male Subjects. Intraindividual Comparison, 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 b.i.d. treatment
- Conditions
- Healthy
- Being tested
- Asasantin ER (new formulation - low), Asasantin ER (new formulation - medium), Asasantin ER (new formulation - high), Asasantin ER - 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 - low)Drug
Asasantin ER (new formulation - medium)Drug
Asasantin ER (new formulation - high)Drug
Asasantin ER - commercial formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Asasantin ER (new formulation - low) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation - low) |
| Asasantin ER (new formulation - medium) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation - medium) |
| Asasantin ER (new formulation- high) | Experimental | Not described Receives: Drug: Asasantin ER (new formulation - high) |
| Asasantin ER - commercial formulation | Active comparator | Not described Receives: Drug: Asasantin ER - commercial formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of dipyridamole
geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)
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 (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 1 month
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 startSep 2002
- Primary completionOct 2002
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
- 16 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
- NCT02273544
- Sponsor's protocol ID
- 9.158
- 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 After Asasantin (Extended Release 200mg Dipyridamole/25mg ASA) in 3 Experimental Formulations (Given b.i.d. Over 3 or 5 Days, Respectively) Relative to the Standard Formulation in 16 Healthy Female and Male Subjects. Intraindividual Comparison, Randomised, Open
- ClinicalTrials.gov ID
- NCT02273544
- Acronym / sponsor ID
- 9.158
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Oct 2002 (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 b.i.d. 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 - low) | Experimental | Drug: Asasantin ER (new formulation - low) |
| Asasantin ER (new formulation - medium) | Experimental | Drug: Asasantin ER (new formulation - medium) |
| Asasantin ER (new formulation- high) | Experimental | Drug: Asasantin ER (new formulation - high) |
| Asasantin ER - commercial formulation | Active comparator | Drug: Asasantin ER - commercial formulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Female subjects are not lactating. Females must use adequate contraception (adequate contraception e.g. sterilization, IUP, oral contraceptives) prior to administration of study medication, during the study until after release from the study. Women must have negative blood pregnancy tests
- Age >= 18 and <= 60 years
- BMI >=18.5 and <=29.9 kg/m2 (see abbreviations for formula)
Key exclusion criteria (28 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 - low) | Drug | Asasantin ER (new formulation - low) |
| Asasantin ER (new formulation - medium) | Drug | Asasantin ER (new formulation - medium) |
| Asasantin ER (new formulation - high) | Drug | Asasantin ER (new formulation- high) |
| Asasantin ER - commercial formulation | Drug | Asasantin ER - commercial formulation |
Primary outcome
Urinary excretion of dipyridamole
Time frame: day 2, day 3
geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)
4 secondary outcomes
Cmax urine (Maximum measured concentration of the analyte)
Time frame: 0 to 3 hours after drug intake
Cmin (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 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
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 - low), Asasantin ER (new formulation - medium) and Asasantin ER (new formulation - 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 7 inclusion and 28 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: stopped early, 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 was stopped early. Results are not available in the source record.
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.