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Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin

NCT00331565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-12-03

No results posted yet for this study

Summary

Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely. Getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs.

In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well.

In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects.

Conditions

  • Morbid Obesity

Interventions

PROCEDURE

Bariatric surgery

Gastric bypass, duodenal switch and sleeve surgery

Sponsors & Collaborators

  • The Hospital of Vestfold

    collaborator OTHER

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Rune Sandbu, MD, PhD · Hospital in Vestfold

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Norway

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 NCT00331565 on ClinicalTrials.gov