Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers

NCT02171507 | Completed Phase 1

• 1 other identifier: 1160.7
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• AUCτ,ss on Day 4 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)

  from pre-dose up to 72 hours post-dose

• Cmax,ss (maximum concentration of dabigatran in plasma at steady state)

  from pre-dose up to 72 hours post-dose

• Cmax (maximal concentration of diclofenac in plasma)

  from pre-dose up to 72 hours post-dose

• AUC0-infinity (area under the concentration-time curve of diclofenac in plasma extrapolated to infinity)

  from pre-dose up to 72 hours post-dose

• aPTT (activated partial thromboplastin time) and ECT (Ecarin clotting time) with and without diclofenac

  from pre-dose up to 72 hours post-dose

• AUERτ,ss (area under the effect ratio-time curve of dabigatran in plasma at steady state over a uniform dosing interval τ)

  from pre-dose up to 72 hours post-dose

• ERmax,ss (maximal effect ratio of dabigatran in plasma at steady state)

  from pre-dose up to 72 hours post-dose

Secondary Outcomes (21)

• AUC0-tz,ss (area under the concentration-time curve of dabigatran in plasma from the time point 0 after the last dose at steady state to the last quantifiable dabigatran plasma concentration within the uniform dosing interval τ)

  from pre-dose up to 72 hours post-dose

• tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)

  from pre-dose up to 72 hours post-dose

• tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state on Day 4)

  from pre-dose up to 72 hours post-dose

• CL/Fss (apparent clearance of dabigatran in the plasma at steady state after extravascular multiple dose administration)

  from pre-dose up to 72 hours post-dose

• CLR,ss (renal clearance of dabigatran at steady state determined over the dosing interval τ)

  from pre-dose up to 72 hours post-dose

Study Arms (3)

Dabigatran etexilate

ACTIVE COMPARATOR

Drug: Dabigatran etexilate

Diclofenac

ACTIVE COMPARATOR

Drug: Diclofenac

Dabigatran etexilate + diclofenac

EXPERIMENTAL

Drug: Dabigatran etexilate; Drug: Diclofenac

Interventions

Dabigatran etexilate DRUG

Dabigatran etexilate; Dabigatran etexilate + diclofenac

Diclofenac DRUG

Dabigatran etexilate + diclofenac; Diclofenac

Eligibility Criteria

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

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
• Age ≥18 and ≤55 years
• Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder including history of gastrointestinal erosions and ulcer 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 is deemed relevant to the objectives of the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran; Diclofenac

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

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: May 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: June 24, 2014

Record last verified: 2014-06