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Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: fluvoxamine (Drug); Digoxin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Karolinska Institutet

Overall contact:
Georgios Panagiotidis, MD PhD DDS, Phone: +46858582678

Summary

The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Cmax of fluvoxamine and of digoxin

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- - Healthy volunteer ≥ 18 years of age

- Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)

- Normal P-potassiumvalue (3,6-4,6 mmol/L)

- HF>50 and no AV-block on resting ECG. No other significant abnormalities as judged by

the investigator.

- Subject giving written informed consent

- Subject capable of understanding instructions

Exclusion Criteria:

- - Pregnancy

- Ongoing infection

- Intake of medication, including natural remedies (for example St John´s wort),

within one month prior to starting study except for paracetamol.

- Active drug or alcohol abuse

Locations and Contacts

Georgios Panagiotidis, MD PhD DDS, Phone: +46858582678

CPTU, Stockholm, Sweden; Recruiting
Additional Information

Starting date: August 2008
Last updated: October 10, 2012

Page last updated: August 23, 2015

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