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Dabigatran in an Interaction Probe Drug Cocktail

NCT02361619 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-14

No results posted yet for this study

Summary

Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Caffeine

probe

DRUG

Diclofenac

probe

DRUG

Esomeprazole

probe

DRUG

Metoprolol

probe

DRUG

Midazolam

probe

DRUG

Dabigatran

probe

DRUG

Clarithromycin

perpetrator

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Petri Vainio, MD PhD · Turku University Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-09-30
Completion
2017-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361619 on ClinicalTrials.gov