Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers

NCT02171559 | Completed Phase 1

• 1 other identifier: 1160.78
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of dabigatran

  Up to 48 hours after drug administration

• Maximum measured concentration of the analyte in plasma (Cmax ) of dabigatran

  Up to 48 hours after drug administration

• Area under the effect-time curve of the analyte in plasma over the time interval from 0 to 48 h after administration (AUEC0-48) after dabigatran alone and after dabigatran following enoxaparin administration

  Up to 48 hours after drug administration

• Maximum effect ratio to baseline (ERmax) after dabigatran alone and after dabigatran following enoxaparin administration

  Baseline and up to 48 hours after drug administration

Secondary Outcomes (18)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) of dabigatran

  Up to 48 hours after drug administration

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

  Up to 48 hours after drug administration

• Terminal rate constant in plasma (λz) of dabigatran

  Up to 48 hours after drug administration

• Terminal half-life of the analyte in plasma (t1/2) of dabigatran

  Up to 48 hours after drug administration

• Mean residence time of the analyte in the body after oral administration (MRTpo) of dabigatran

  Up to 48 hours after drug administration

Study Arms (2)

Dabigatran etexilate capsules after enoxaparin ampoules

EXPERIMENTAL

Drug: Enoxaparin prefilled syringes; Drug: Dabigatran etexilate capsules

Dabigatran etexilate capsules without enoxaparin

ACTIVE COMPARATOR

Drug: Dabigatran etexilate capsules

Interventions

Enoxaparin prefilled syringes DRUG

Dabigatran etexilate capsules after enoxaparin ampoules

Dabigatran etexilate capsules DRUG

Dabigatran etexilate capsules after enoxaparin ampoules; Dabigatran etexilate capsules without enoxaparin

Eligibility Criteria

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

You may qualify if:

• Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
• Age ≥18 to ≤55 years
• Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant 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 any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 4 weeks prior to administration or during the trial
• Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)
• Drug abuse
• Intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's wort within 5 days of first dosing
• Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial
• Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)
• Excessive physical activities (within 1 week prior to trial drug administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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 24, 2014
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06