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Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery

NCT07748273 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-05

No results posted yet for this study

Summary

This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan. Sixty adults scheduled for bariatric surgery will enter one of two parallel groups according to the clinically selected operation (30 RYGB and 30 sleeve gastrectomy). Each participant will receive rosuvastatin 10 mg and losartan 25 mg once within 30 days before surgery and again approximately 12 weeks after surgery. Plasma samples collected before dosing and at 1.5 and 4 hours after dosing will be used with maximum a posteriori Bayesian estimation to estimate individual pharmacokinetic parameters. In the 30-participant RYGB group only, paired stool samples will be used to explore gut microbiota and untargeted fecal metabolomic changes. The primary objective is to compare within-participant changes and between-procedure differences in drug exposure after bariatric surgery.

Conditions

  • Obesity & Overweight
  • Bariatric Surgery
  • Pharmacokinetics After Oral Intake
  • Drug Absorption

Interventions

DRUG

Rosuvastatin

Rosuvastatin 10 mg tablet, single oral dose at each of two pharmacokinetic visits. Other name: rosuvastatin calcium.

DRUG

Losartan (Control)

Losartan 25 mg tablet, single oral dose at each of two pharmacokinetic visits. Other name: losartan potassium.

Sponsors & Collaborators

  • School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo

    collaborator UNKNOWN

  • Hospital das Clínicas de Ribeirão Preto

    lead OTHER

Principal Investigators

  • Wilson Salgado Jr, MD PhD · Medical School of Ribeirao Preto, University of Sao Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-02
Primary Completion
2027-05-15
Completion
2027-05-15

Countries

  • Brazil

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 NCT07748273 on ClinicalTrials.gov