HealthyPhase 1NCT02259998
Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers
A Phase 1 study testing Persantin® new formulation and Persantin® commercial formulation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Persantin® new formulation and Persantin® commercial formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study should be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2
- All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- 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
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 20Show 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 before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
- Following exclusion criteria are of special interest for this study:
- History of haemorrhagic diathesis
- History of gastro-intestinal ulcer, perforation or bleeding
- Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency
About this study
Official title: An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
- Conditions
- Healthy
- Being tested
- Persantin® new formulation, Persantin® commercial formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persantin® new formulationDrug
Persantin® commercial formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Persantin® new formulation | Experimental | Not described Receives: Drug: Persantin® new formulation |
| Persantin® commercial formulation | Active comparator | Not described Receives: Drug: Persantin® 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 from 48 to 58 hours (AUC48-58)
Measured: 48 - 58 hours
Maximum concentration from 48 to 58 hours (Cmax48-58)
Measured: 48 - 58 hours
Secondary outcomes (9)
Peak trough fluctuation (% PTF)
Measured: up to 48 hours
Minimum concentration from 48 to 58 hours (Cmin48-58)
Measured: 48 - 58 hours
Cmax48-58/AUC48-58 ratio
Measured: 48 - 58 hours
Time to maximum concentration from 48 to 58 hours (Tmax48-58)
Measured: up to 58 hours
Amount excreted in urine (Ae)
Measured: up to 24 hours after drug administration
Number of participants with adverse events
Measured: up to 8 days after last drug administration
Number of participants with clinically significant findings in vital functions
blood pressure, pulse rate
Measured: up to 8 days after last drug administration
Number of participants with clinically significant findings in ECG
Measured: up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Measured: up to 8 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2001
- Primary completionDec 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
- None (open label)
- Enrolment
- 30 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
- NCT02259998
- Sponsor's protocol ID
- 21.449
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02259998
- Acronym / sponsor ID
- 21.449
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Dec 2001 (actual)
- First posted
- 9 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.
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persantin® new formulation | Experimental | Drug: Persantin® new formulation |
| Persantin® commercial formulation | Active comparator | Drug: Persantin® commercial formulation |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants in the study should be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2
- All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- 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
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 |
|---|---|---|
| Persantin® new formulation | Drug | Persantin® new formulation |
| Persantin® commercial formulation | Drug | Persantin® commercial formulation |
Primary outcome
Area under the concentration time curve from 48 to 58 hours (AUC48-58)
Time frame: 48 - 58 hours
Maximum concentration from 48 to 58 hours (Cmax48-58)
Time frame: 48 - 58 hours
9 secondary outcomes
Peak trough fluctuation (% PTF)
Time frame: up to 48 hours
Minimum concentration from 48 to 58 hours (Cmin48-58)
Time frame: 48 - 58 hours
Cmax48-58/AUC48-58 ratio
Time frame: 48 - 58 hours
Time to maximum concentration from 48 to 58 hours (Tmax48-58)
Time frame: up to 58 hours
Amount excreted in urine (Ae)
Time frame: up to 24 hours after drug administration
Number of participants with adverse events
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in vital functions
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Time frame: up to 8 days after last 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 9 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 Persantin® new formulation and Persantin® 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 2 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 9 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 from 48 to 58 hours (AUC48-58) (time frame: 48 - 58 hours). 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 9 Oct 2014.