Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

NCT ID: NCT02222987

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28

Brief Summary

Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terbogrel

Group Type: ACTIVE_COMPARATOR

Terbogrel

Intervention Type: DRUG

Terbogrel with Clopidogrel

Group Type: EXPERIMENTAL

Terbogrel

Intervention Type: DRUG

Clopidogrel

Intervention Type: DRUG

Clopidogrel

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Interventions

Terbogrel

Intervention Type: DRUG

Clopidogrel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Healthy male subjects
• Age >= 18 and <= 45 years
• Broca >= -20% and <= +20 %

Exclusion Criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of

• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic disease
• cerebral bleeding (e.g. after car accident)
• commotio cerebri
• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol (> 60 g/day) abuse
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the reference range of clinical relevance
• History of any familial bleeding disorder
• Thrombocytes < 150000/µl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

528.23

Identifier Type: -

Identifier Source: org_study_id