HealthyPhase 1NCT02273518
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
A Phase 1 study testing Asasantin ER, new formulation I, Asasantin ER, new formulation II and Asasantin ER, present commercial formulation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin ER, new formulation I, Asasantin ER, new formulation II and Asasantin ER, present commercial formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to May 2001
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Who cannot join
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 26Show fewer
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
- Conditions
- Healthy
- Being tested
- Asasantin ER, new formulation I, Asasantin ER, new formulation II, 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 IDrug
Asasantin ER, new formulation IIDrug
Asasantin ER, present commercial formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Asasantin ER, new formulation I | Experimental | Not described Receives: Drug: Asasantin ER, new formulation I |
| Asasantin ER, new formulation II | Experimental | Not described Receives: Drug: Asasantin ER, new formulation II |
| 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 at steady state (AUC,ss)
Measured: Up to 48 hours after start of drug administration
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Measured: Up to 48 hours after start of drug administration
Secondary outcomes (11)
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Measured: Up to 48 hours after start of drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: Up to 48 hours after start of drug administration
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Measured: Up to 48 hours after start of drug administration
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Measured: Up to 48 hours after start of drug administration
Terminal half-life of the analytes in plasma (t1/2)
Measured: Up to 48 hours after start of drug administration
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Measured: Up to 24 hours after start of drug administration
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
Measured: Up to 48 hours after start of drug administration
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Measured: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
Measured: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in laboratory values
Measured: up to 8 days after last study drug administration
Number of subjects with adverse events
Measured: up to 8 days after last study drug administration
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 startApr 2001
- Primary completionMay 2001
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
- Double blind
- Enrolment
- 18 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
- NCT02273518
- Sponsor's protocol ID
- 9.144
- 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
- A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02273518
- Acronym / sponsor ID
- 9.144
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- May 2001 (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.
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asasantin ER, new formulation I | Experimental | Drug: Asasantin ER, new formulation I |
| Asasantin ER, new formulation II | Experimental | Drug: Asasantin ER, new formulation II |
| Asasantin ER, present commercial formulation | Active comparator | Drug: Asasantin ER, present commercial formulation |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
Key exclusion criteria (26 listed)
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with 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 I | Drug | Asasantin ER, new formulation I |
| Asasantin ER, new formulation II | Drug | Asasantin ER, new formulation II |
| Asasantin ER, present commercial formulation | Drug | Asasantin ER, present commercial formulation |
Primary outcome
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Time frame: Up to 48 hours after start of drug administration
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Time frame: Up to 48 hours after start of drug administration
11 secondary outcomes
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Time frame: Up to 48 hours after start of drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 48 hours after start of drug administration
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Time frame: Up to 48 hours after start of drug administration
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Time frame: Up to 48 hours after start of drug administration
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 48 hours after start of drug administration
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Time frame: Up to 24 hours after start of drug administration
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
Time frame: Up to 48 hours after start of drug administration
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
Time frame: up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in laboratory values
Time frame: up to 8 days after last study drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last study drug administration
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Asasantin ER, new formulation II 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 6 inclusion and 26 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 at steady state (AUC,ss) (time frame: Up to 48 hours after start of drug administration). 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.