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Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.

NCT02983890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-23

No results posted yet for this study

Summary

This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence, two-period crossover, cocktail study where a combination of cocktail-drugs is used to illustrate whether or not, or to what degree dicloxacillin affects the level of activity of the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious drug-drug interactions.

Conditions

  • Healthy

Interventions

DRUG

Dicloxacillin

Tablets containing dicloxacillin are taken 500mg 2x 3 times per day, for 10 days. Followed by test-day nr 1 at day 11. Both arms receives both treatments, randomly assigned

DRUG

Placebos

No drug are taken for 10 days. Non-blinded. Followed by test-day nr 1 at day 11. Both arms receives both treatments, randomly assigned

Sponsors & Collaborators

  • Per Damkier

    lead OTHER

Principal Investigators

  • Per Damkier, Ph.d. · Assosiated to department of biochemistry and pharmacology at University of southern denmark, Odense

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2017-04-05
Completion
2017-10-01

Countries

  • Denmark

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 NCT02983890 on ClinicalTrials.gov