Clinical trial NCT02259998: Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Area under the concentration time curve from 48 to 58 hours (AUC48-58)
timeFrame: 48 - 58 hours
measure: Maximum concentration from 48 to 58 hours (Cmax48-58)
timeFrame: 48 - 58 hours
Secondary outcomes:
measure: Peak trough fluctuation (% PTF)
timeFrame: up to 48 hours
measure: Minimum concentration from 48 to 58 hours (Cmin48-58)
timeFrame: 48 - 58 hours
measure: Cmax48-58/AUC48-58 ratio
timeFrame: 48 - 58 hours
measure: Time to maximum concentration from 48 to 58 hours (Tmax48-58)
timeFrame: up to 58 hours
measure: Amount excreted in urine (Ae)
timeFrame: up to 24 hours after drug administration
measure: Number of participants with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in vital functions
timeFrame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in ECG
timeFrame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
Other outcomes:
Locations:
Study officials:
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