Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects

NCT ID: NCT02264106

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30

Brief Summary

To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole

Conditions

Healthy

Study Design

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

Study Groups

Lefradafiban tablet with pantoprazole

Group Type: EXPERIMENTAL

Lefradafiban tablet

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

Lefradafiban tablet

Group Type: ACTIVE_COMPARATOR

Lefradafiban tablet

Intervention Type: DRUG

Lefradafiban double chamber sachet with pantoprazole

Group Type: EXPERIMENTAL

Lefradafiban double chamber sachet

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

Lefradafiban double chamber sachet

Group Type: ACTIVE_COMPARATOR

Lefradafiban double chamber sachet

Intervention Type: DRUG

Interventions

Lefradafiban tablet

Intervention Type: DRUG

Lefradafiban double chamber sachet

Intervention Type: DRUG

Pantoprazole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 60 years, planned stratification: age < 40 years (4 subjects) and ≥ 40 years (8 subjects)
• Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria

• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Drug abuse
• Alcohol abuse (> 60 g/day)
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Excessive physical activities within 5 days prior to administration or during the trial
• Blood donation within 1 month prior to administration or during the trial
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
• Chronic or relevant acute infections
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• 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 a car accident
• Recent surgical procedures
• Thrombocytes < 150000/µ
• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Any laboratory value outside the clinically accepted reference range
• Other disease or abnormality of clinical relevance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

509.118

Identifier Type: -

Identifier Source: org_study_id