Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

NCT02170792 | Completed Phase 1

• 1 other identifier: 1160.16
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)

  before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

• Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)

  before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

Secondary Outcomes (9)

• Maximum concentration of drug in plasma ( Cmax )

  before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

• Time from dosing to the maximum concentration of the analyte in plasma (tmax)

  before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment

• Changes from baseline in Pulse rate

  baseline up to 36 h after last administration

• Changes from baseline in blood pressure (systolic and diastolic)

  baseline up to 36 h after last administration

• Changes from baseline in ECG

  baseline up to 36 h after last administration

Study Arms (2)

BIBR 1048 MS with ranitidine

EXPERIMENTAL

Low, medium or high dose in combination with ranitidine

Drug: BIBR 1048 MS; Drug: Ranitidine

BIBR 1048 MS without ranitidine

EXPERIMENTAL

Low, medium or high dose

Drug: BIBR 1048 MS

Interventions

BIBR 1048 MS DRUG

Low, medium or high dose

BIBR 1048 MS with ranitidine; BIBR 1048 MS without ranitidine

Ranitidine DRUG

150mg

Also known as: Zantic ®

BIBR 1048 MS with ranitidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male subjects as determined by results of screening
• signed written informed consent in accordance with GCP and local legislation
• age \>= 18 and \<= 50 years
• Broca \>= - 20% and \<0 + 20%

You may not qualify if:

• any finding of the medical examination (including blood pressure, pulse rate and ECG)
• history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• history of orthostatic hypotension, fainting spells and blackouts
• diseases of central nervous system (such as epilepsy) or psychiatric disorders
• chronic or relevant acute infections
• 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)
• commotio cerebri
• intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
• use of any drugs which might influence the results of the trial within 10 days prior to administration or during administration
• participation in another trial with an investigational drug within 2 month prior to administration or during trial
• smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ranitidine

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: June 20, 2014
• First Posted: June 23, 2014
• Study Start: February 1, 2001
• Primary Completion: March 1, 2001
• Last Updated: June 23, 2014

Record last verified: 2014-06