Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

NCT ID: NCT02264197

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31

Brief Summary

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety

Conditions

Healthy

Study Design

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

Study Groups

BIBX 245 CL - fed

after a light breakfast with 40 g fat

Group Type: EXPERIMENTAL

BIBX 245 CL - fed

Intervention Type: DRUG

BIBX 245 CL - fasted

Group Type: ACTIVE_COMPARATOR

BIBX 245 CL- fasted

Intervention Type: DRUG

Interventions

BIBX 245 CL - fed

Intervention Type: DRUG

BIBX 245 CL- fasted

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 50 years
• Broca >= -20% and <= +20%

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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) (<= 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial)
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
• Excessive physical activities (<= 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range or clinical relevance

• Minimum Eligible Age: 18 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

537.7

Identifier Type: -

Identifier Source: org_study_id