Infections, Bacterial Clinical Trial
Official title:
Evaluation of Pharmaceutical Bioequivalence of Amoxicillin Trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the Form Powder for Oral Suspension Versus Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the Form of Powder for Oral Suspension in Healthy Volunteers and Fasting, Using Techniques of Liquid Chromatography
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The objective is to confirm if two formulations of Amoxicillin trihydrate, in the form powder for oral suspension, are bioequivalent. The test product is Amoxicillin trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the form powder for oral suspension and reference product is Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the form of powder for oral suspension. Twenty eight healthy volunteers, of both genders, were evaluated. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions. In each period blood samples are collected in the following times: 0.00 (prior to administration of medication); 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 (after administration of medication). The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04079790 -
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
|
Phase 1 | |
| Completed |
NCT01934205 -
To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944
|
Phase 1 | |
| Not yet recruiting |
NCT02177721 -
Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis
|
Phase 4 | |
| Suspended |
NCT01132417 -
In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
|
N/A | |
| Completed |
NCT00539994 -
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
|
Phase 2 | |
| Completed |
NCT01610388 -
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01262885 -
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT00427141 -
A Three-Part Study Of GSK580416 In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04620486 -
Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial
|
N/A | |
| Recruiting |
NCT06451172 -
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
|
Early Phase 1 | |
| Not yet recruiting |
NCT06440304 -
Therapeutic Options for CRAB
|
Phase 4 | |
| Completed |
NCT02292498 -
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
|
N/A | |
| Completed |
NCT01587768 -
WEUKBRE5555: IMI PROTECT(Work Package 2): Liver Injury & Antibiotics
|
N/A | |
| Withdrawn |
NCT01039610 -
A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose and Repeat Escalating Oral Doses of GSK945237; the Effect of Linezolid on Hematology Safety Parameters; and the Effects of GSK945237 and Moxifloxacin on QTc.
|
Phase 1 | |
| Completed |
NCT00259909 -
Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
N/A | |
| Completed |
NCT00828867 -
Single Dose Escalation First Time in Human PK Study
|
Phase 1 | |
| Completed |
NCT02778672 -
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
|
N/A | |
| Completed |
NCT00896558 -
A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02045797 -
Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
|
Phase 2 | |
| Active, not recruiting |
NCT05752019 -
TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
|