HealthyPhase 1NCT02273531
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers
A Phase 1 study testing Asasantin ER, new formulation and Asasantin ER, present commercial formulation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®) Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin ER, new formulation and Asasantin ER, present commercial formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Mar 2004
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests:
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 21 and ≤ 65 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Able to communicate well with the investigator and to comply with study requirements
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 24Show fewer
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- History of frequent headaches
- History of gastro-intestinal ulcer disease
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Bioequivalence of a New Asasantin Capsule Formulation (Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Compared to the Commercially Available Asasantin Capsule Formulation (Aggrenox®; Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Following Multiple Oral Administration at Steady State After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg, 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [Asasantin ER])- an Open Label, Randomized, Multiple-dose, Two-way Crossover, Change-over Study in Healthy Male and Female Volunteers
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
- Conditions
- Healthy
- Being tested
- Asasantin ER, new formulation, 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 formulationDrug
Asasantin ER, present commercial formulationDrug
Also called Aggrenox®
| Study group | Role | What they receive |
|---|---|---|
| Asasantin ER, new formulation | Experimental | Not described Receives: Drug: Asasantin ER, new formulation |
| 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.
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
Measured: up to 17 days
Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
Measured: up to 17 days
Secondary outcomes (11)
Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
Measured: up to 17 days
Average concentration of dipyridamole in plasma at steady state (Cavg)
Measured: up to 17 days
Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
Measured: up to 17 days
Peak trough fluctuation of dipyridamole in plasma (PTF)
Measured: up to 17 days
Amount of the analytes that were eliminated in urine (Ae)
Measured: up to 24 hours after drug administration
Fraction in percent of dose of the analytes that was eliminated in urine (fe)
Measured: up to 24 hours after drug administration
Number of subjects with clinically significant changes in 12-lead ECG
Measured: up to 17 days
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Measured: up to 17 days
Number of subjects with clinically significant changes in laboratory tests
Measured: up to 17 days
Number of subjects with adverse events
Measured: up to 17 days
Assessment of tolerability by the investigator on a 4-point scale
Measured: after 17 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 2004
- Primary completionMar 2004
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
- 24 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
- NCT02273531
- Sponsor's protocol ID
- 9.149
- 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
- Bioequivalence of a New Asasantin Capsule Formulation (Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Compared to the Commercially Available Asasantin Capsule Formulation (Aggrenox®; Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Following Multiple Oral Administration at Steady State After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg, 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [Asasantin ER])- an Open Label, Randomized, Multiple-dose, Two-way Crossover, Change-over Study in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02273531
- Acronym / sponsor ID
- 9.149
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Mar 2004 (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.
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asasantin ER, new formulation | Experimental | Drug: Asasantin ER, new formulation |
| Asasantin ER, present commercial formulation | Active comparator | Drug: Asasantin ER, present commercial formulation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests:
- Age ≥ 21 and ≤ 65 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Able to communicate well with the investigator and to comply with study requirements
Key exclusion criteria (24 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 | Drug | Asasantin ER, new formulation |
| Asasantin ER, present commercial formulationAlso: Aggrenox® | Drug | Asasantin ER, present commercial formulation |
Primary outcome
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
Time frame: up to 17 days
Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
Time frame: up to 17 days
11 secondary outcomes
Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
Time frame: up to 17 days
Average concentration of dipyridamole in plasma at steady state (Cavg)
Time frame: up to 17 days
Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
Time frame: up to 17 days
Peak trough fluctuation of dipyridamole in plasma (PTF)
Time frame: up to 17 days
Amount of the analytes that were eliminated in urine (Ae)
Time frame: up to 24 hours after drug administration
Fraction in percent of dose of the analytes that was eliminated in urine (fe)
Time frame: up to 24 hours after drug administration
Number of subjects with clinically significant changes in 12-lead ECG
Time frame: up to 17 days
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 17 days
Number of subjects with clinically significant changes in laboratory tests
Time frame: up to 17 days
Number of subjects with adverse events
Time frame: up to 17 days
Assessment of tolerability by the investigator on a 4-point scale
Time frame: after 17 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 and Asasantin ER, present commercial formulation 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 24 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?
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss) (time frame: up to 17 days). The study lists 2 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 24 Oct 2014.