Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects

NCT ID: NCT02266498

Last Updated: 2014-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30

Brief Summary

To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules

Conditions

Healthy

Study Design

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

Study Groups

BIBB 515 BS after a standard breakfast

Group Type: EXPERIMENTAL

BIBB 515 BS

Intervention Type: DRUG

Standard breakfast (40 g fat)

Intervention Type: OTHER

BIBB 515 BS

Group Type: ACTIVE_COMPARATOR

BIBB 515 BS

Intervention Type: DRUG

Interventions

BIBB 515 BS

Intervention Type: DRUG

Standard breakfast (40 g fat)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy male caucasian subjects as determined by results of screening
• 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 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 of 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

525.4

Identifier Type: -

Identifier Source: org_study_id