Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin
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|ClinicalTrials.gov Identifier: NCT03588273|
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 18, 2018
The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin.
Methods: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n=8) received amoxicillin 500 mg capsule orally before and 2 months after the Roux-en-Y gastric bypass surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS).
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Candidate||Drug: Amoxil 500 MG Oral Capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Monocentric, open-label, single-dose study with two treatment periods - before the surgery (Time 0 - T0) and 2 months after the bariatric surgery (Time 2 - T2).|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin|
|Actual Study Start Date :||June 24, 2016|
|Actual Primary Completion Date :||April 3, 2017|
|Actual Study Completion Date :||April 3, 2017|
Amoxil 500 mg Oral Capsule Time 0
In each period (before the surgery and 2 months after the bariatric surgery) the obese volunteers received a single oral dose of amoxicillin 500 mg capsule (Amoxil®, GlaxoSmithKline Brazil Ltda.) with 200 mL water after an overnight fast (approximately 8 h).
Drug: Amoxil 500 MG Oral Capsule
- Change on the plasma concentration of amoxicillin [ Time Frame: Before and 2 months after bariatric surgery. ]Blood samples (6 mL) for determination of plasma concentration of amoxicillin were collected via a venous catheter into heparinized tubes at pre-dose (0 h), 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h post-dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588273
|Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara|
|Fortaleza, CE, Brazil, 60430-275|
|Principal Investigator:||Maria Elisabete A De Moraes, MD, PhD||Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)|