[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-absorption\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-absorption":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100650369","rosuvastatin-and-losartan-pharmacokinetics-after-bariatric-surgery-100650369",false,"NCT07748273","Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery","Comparative Evaluation of Rosuvastatin and Losartan Pharmacokinetics and the Associations Between Gut Microbiota Alterations and Changes in Systemic Drug Exposure in Patients Undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy","BARI-PK","Inclusion Criteria:\n\n* Adults aged 18 to 65 years;\n* Formal clinical indication for RYGB or sleeve gastrectomy after multidisciplinary assessment;\n* Bariatric surgery scheduled and no previous bariatric procedure;\n* Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Moderate or severe hepatic impairment, liver enzymes greater than 3 times the upper limit of normal, or Child-Pugh class B or C.\n* Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m².\n* Concomitant use of drugs that substantially affect rosuvastatin pharmacokinetics and cannot be temporarily discontinued, including cyclosporine, gemfibrozil, or potent OATP1B1\u002FBCRP or CYP2C9 inhibitors.\n* Systemic antibiotic use within 3 months or probiotic, prebiotic, or synbiotic use within 4 weeks before sampling.\n* Continuous current rosuvastatin or other statin therapy unless medically discontinued with an adequate washout period under physician supervision.\n* Clinically relevant baseline hypotension, significant hyperkalemia, renal impairment, or another condition that makes a losartan test dose unsafe.\n* Severe postoperative complication preventing oral dosing, including active gastrointestinal leak, intractable vomiting, or severe anastomotic stenosis.\n* Pregnancy. Participants of childbearing potential undergo routine preoperative beta-hCG testing.","ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"Obesity & Overweight","Bariatric Surgery","Pharmacokinetics After Oral Intake","Drug Absorption",[33,34,35,36,37,38,39,40],"Roux-en-Y gastric bypass","sleeve gastrectomy","rosuvastatin","losartan","E-3174","gut microbiota","metabolomics","systemic exposure","NOT_YET_RECRUITING","2026-08-03",{"date":44,"type":45},"2026-08-05","ACTUAL",{"date":47,"type":22},"2026-08-02",{"date":49,"type":22},"2027-05-15",{"name":51,"class":52},"Hospital das Clínicas de Ribeirão Preto","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100433019","phase-1-effect-of-gamma-cyclodextrin-on-the-bioavailability-of-berberine-100433019","NCT04918667","Effect of Gamma-cyclodextrin on the Bioavailability of Berberine","A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy volunteers, as determined by medical history, physical examination, and clinical laboratory testing,\n* Willingness to stay in the unit overnight for the duration of the study,\n* Provide a signed written informed consent.\n\nExclusion Criteria:\n\n* overweight (BMI \\>35 kg\u002Fm2),\n* pregnancy,\n* lactation,\n* drug abuse,\n* use of dietary supplements or any form of medication (with the exception of oral contraceptives),\n* heavy smokers, or ex-smokers with a remote history (\\> one pack\u002Fday),\n* frequent alcohol consumption (\\>20 g ethanol\u002Fd),\n* adherence to a restrictive dietary regimen,\n* physical activity of more than 5 h\u002Fwk,\n* respiratory tract infections, or suspicion thereof in the last 14 days before dosing,\n* history or presence of disease in the kidneys and heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs,\n* malignancy,\n* autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis,\n* any other disease or condition, which, in the opinion of the Investigator, would make the subject unsuitable for this study,\n* currently taking medications known to be CYP2C9 inducers (i.e., carbamazepine and rifampicin).",true,"60 Years",{"count":64,"type":22},16,[66],"PHASE1","In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy subjects after oral administration of:\n\nA. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).",[31],[70,71,72,73,74],"Berberine","gamma-cyclodextrin","Pharmacokinetic","Bioavailability","Berberine MetX™ Ultra Absorption","2023-09-12",{"date":77,"type":45},"2023-09-14",{"date":79,"type":22},"2024-09",{"date":81,"type":22},"2026-12",{"name":83,"class":84},"EuroPharma, Inc.","INDUSTRY",4]