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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Persantin® new formulation; Drug: Persantin® commercial formulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Persantin® new formulation	Drug: Persantin® new formulation
Active Comparator: Persantin® commercial formulation	Drug: Persantin® commercial formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
Number of participants with adverse events		up to 8 days after last drug administration
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 clinically significant findings in vital functions	blood pressure, pulse rate	up to 8 days after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): December 1, 2001

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Phosphodiesterase Inhibitors; Dipyridamole
• Other Study ID Numbers: 21.449