Background: A very strict control of urinary pH is recommended to maintain it between 5.5 and 6.2, preventing formation or recurrence of crystals. Kidney stones are a common problem, with a high rate of recurrence, no...Background: A very strict control of urinary pH is recommended to maintain it between 5.5 and 6.2, preventing formation or recurrence of crystals. Kidney stones are a common problem, with a high rate of recurrence, not altered by the success of surgery. Medical treatment prevents recurrence. Potassium Citrate inhibits crystallization of calcium salts. It influences calculogenesis by increasing urinary citrates and alkalinizing the urine. Purpose: to evaluate the similarity in the effect of three K citrate products, K citrate reference product Urocit®10 mEq, and K citrate from Laboratorios LETI S.A.V., 10 mEq and 15 mEq, on urinary pH. Materials and Methods: We carried out a prospective, randomized study of three parallel groups. We admitted female and male patients with history of kidney stones or evidence of lithiasis (grit, microlithiasis) in the renal echosonogram. Laboratory assessments: urine, 24-hour urine, urinary pH, Calcium, uric acid, Phosphorus, Sodium, protein and urinary creatinine at times: start, day 7, day 21, 30 of treatment. Results: all three products produced a slight increase in urinary pH in the simple urine test and 24-hour urine, with no differences between groups or their logarithmically transformed means and their CI95, which did not exceed the range between 80% and 125%. Conclusions: K Citrate, 10 mEq and 7.5 mEq, from Laboratorios LETI, S.A.V., at a dose of 30 mEq daily in patients with history of kidney stones are equivalent to the reference product Urocit®, in its effects on urinary pH in 24-hour urine, and in the simple urine test.展开更多
Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: This was a randomized, single-dose, ope...Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: This was a randomized, single-dose, open-label, two-period, two-sequence, crossover and single-dose study to compare the bioequivalence (BE) profile of Metformin (metformin hydrochloride) 1000 mg XR tablet of Laboratorios Leti S.A.V., with Glucophage® (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters Cmax, AUC0−tand AUC0→∞were calculated based on the plasma drug concentration-time profile measured by liquid chromatography-mass spectrometry (LC-MS/MS). The safety was assessed throughout the study. The two formulations test (T) and reference (R) were considered bioequivalent if 90% confidence interval (CI) were within BE acceptance range of 80.00% - 125.00% for Cmax, AUC0−tand AUC0→∞. Results: A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were Cmax: 92.30% (89.08% - 96.97%), AUC0−t: 91.83% (87.11% - 94.11%) and AUC0→∞: 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted bioequivalence criteria. The results show that no significant differences were observed between the pharmacokinetic profiles of the T and R formulations. No serious adverse events were reported in this study. Conclusion: The two formulations of metformin hydrochloride 1000 mg XR were bioequivalent in healthy subjects under fasting conditions.展开更多
Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical ef...Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.展开更多
文摘Background: A very strict control of urinary pH is recommended to maintain it between 5.5 and 6.2, preventing formation or recurrence of crystals. Kidney stones are a common problem, with a high rate of recurrence, not altered by the success of surgery. Medical treatment prevents recurrence. Potassium Citrate inhibits crystallization of calcium salts. It influences calculogenesis by increasing urinary citrates and alkalinizing the urine. Purpose: to evaluate the similarity in the effect of three K citrate products, K citrate reference product Urocit®10 mEq, and K citrate from Laboratorios LETI S.A.V., 10 mEq and 15 mEq, on urinary pH. Materials and Methods: We carried out a prospective, randomized study of three parallel groups. We admitted female and male patients with history of kidney stones or evidence of lithiasis (grit, microlithiasis) in the renal echosonogram. Laboratory assessments: urine, 24-hour urine, urinary pH, Calcium, uric acid, Phosphorus, Sodium, protein and urinary creatinine at times: start, day 7, day 21, 30 of treatment. Results: all three products produced a slight increase in urinary pH in the simple urine test and 24-hour urine, with no differences between groups or their logarithmically transformed means and their CI95, which did not exceed the range between 80% and 125%. Conclusions: K Citrate, 10 mEq and 7.5 mEq, from Laboratorios LETI, S.A.V., at a dose of 30 mEq daily in patients with history of kidney stones are equivalent to the reference product Urocit®, in its effects on urinary pH in 24-hour urine, and in the simple urine test.
文摘Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: This was a randomized, single-dose, open-label, two-period, two-sequence, crossover and single-dose study to compare the bioequivalence (BE) profile of Metformin (metformin hydrochloride) 1000 mg XR tablet of Laboratorios Leti S.A.V., with Glucophage® (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters Cmax, AUC0−tand AUC0→∞were calculated based on the plasma drug concentration-time profile measured by liquid chromatography-mass spectrometry (LC-MS/MS). The safety was assessed throughout the study. The two formulations test (T) and reference (R) were considered bioequivalent if 90% confidence interval (CI) were within BE acceptance range of 80.00% - 125.00% for Cmax, AUC0−tand AUC0→∞. Results: A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were Cmax: 92.30% (89.08% - 96.97%), AUC0−t: 91.83% (87.11% - 94.11%) and AUC0→∞: 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted bioequivalence criteria. The results show that no significant differences were observed between the pharmacokinetic profiles of the T and R formulations. No serious adverse events were reported in this study. Conclusion: The two formulations of metformin hydrochloride 1000 mg XR were bioequivalent in healthy subjects under fasting conditions.
文摘Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.
