Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pravastatin

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 given

• Age ≥ 18 and ≤ 65 years

• Broca ≥ - 20 % and ≤ + 30 %

• Cholesterol level ≥ 5.4 mmol/l

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 was 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

• Abnormal findings at eye lens examination