Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers

Study Overview
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Brief Summary
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To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Persantin® new formulation
* Drug: Persantin® commercial formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persantin® new formulation<br> | Drug: Persantin® new formulation<br> <br> |
| Active Comparator: Persantin® commercial formulation<br> | Drug: Persantin® commercial formulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve from 48 to 58 hours (AUC48-58) |  | 48 - 58 hours | 
| Maximum concentration from 48 to 58 hours (Cmax48-58) |  | 48 - 58 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak trough fluctuation (% PTF) |  | up to 48 hours | 
| Minimum concentration from 48 to 58 hours (Cmin48-58) |  | 48 - 58 hours | 
| Cmax48-58/AUC48-58 ratio |  | 48 - 58 hours | 
| Time to maximum concentration from 48 to 58 hours (Tmax48-58) |  | up to 58 hours | 
| Amount excreted in urine (Ae) |  | up to 24 hours after drug administration | 
| Number of participants with adverse events |  | up to 8 days after last drug administration | 
| Number of participants with clinically significant findings in vital functions | blood pressure, pulse rate | up to 8 days after last drug administration | 
| Number of participants with clinically significant findings in ECG |  | up to 8 days after last drug administration | 
| Number of participants with clinically significant findings in laboratory tests |  | up to 8 days after last drug administration |