Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects

NCT02223000 | Completed Phase 1

• 1 other identifier: 528.22
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral solution of BIBV 308 SE following multiple doses, tolerability

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve of the analyte in plasma at steady state (AUCss)

  up to 84 hours after drug administration

• Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)

  up to 84 hours after drug administration

• Minimum measured concentration of the analyte in plasma at steady state (Cmin,ss)

  up to 84 hours after drug administration

Secondary Outcomes (6)

• Percent peak-trough fluctuation (%PTF)

  up to 84 hours after drug administration

• Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)

  up to 84 hours after drug administration

• Mean residence time of the analyte in the body (MRTtot)

  up to 84 hours after drug administration

• Apparent clearance of the analyte in plasma (CL/f)

  up to 84 hours after drug administration

• Ratio of Cmax,ss/AUCss

  up to 84 hours after drug administration

Study Arms (3)

BIBV 308 SE solution

ACTIVE COMPARATOR

Drug: BIBV 308 SE solution

BIBV 308 SE capsule 1

EXPERIMENTAL

Drug: BIBV 308 SE capsule 1

BIBV 308 SE capsule 2

EXPERIMENTAL

Drug: BIBV 308 SE capsule 2

Interventions

BIBV 308 SE solution DRUG

BIBV 308 SE solution

BIBV 308 SE capsule 1 DRUG

BIBV 308 SE capsule 1

BIBV 308 SE capsule 2 DRUG

BIBV 308 SE capsule 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age \>= 18 and \<= 55 years
• Broca \>= -20% and \<= +20 %

You may not qualify if:

• Poor individual absorption kinetics of BIBV 308 SE in previous studies
• Any findings 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 the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• Hypersensitivity to BIBV 308 SE and any of the excipients
• 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 days 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
• Known alcohol or drug abuse
• Blood donation \<= 1 month prior to administration
• Excessive physical activities \<= 5 days prior to administration

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: March 1, 1998
• Primary Completion: July 1, 1998
• Last Updated: August 22, 2014

Record last verified: 2014-08