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

NCT ID: NCT02259998

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Persantin® new formulation

Group Type: EXPERIMENTAL

Persantin® new formulation

Intervention Type: DRUG

Persantin® commercial formulation

Group Type: ACTIVE_COMPARATOR

Persantin® commercial formulation

Intervention Type: DRUG

Interventions

Persantin® new formulation

Intervention Type: DRUG

Persantin® commercial formulation

Intervention Type: DRUG

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

• History of haemorrhagic diathesis
• History of gastro-intestinal ulcer, perforation or bleeding
• Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

21.449

Identifier Type: -

Identifier Source: org_study_id