76; 95% confidence interval (95% CI) 0.56-1.01; p=0.06) (heterogeneity I
=34%). We recorded 222 adverse events in 2,742 patients treated with bemiparin and 288 adverse events in 2,731 patients treated with enoxaparin (8.1 vs. 10.5 adverse events per 100 patients, respectively; p=0.003). However, the meta-analysis for safety showed a significant heterogeneity making not possible to pool the result across the trials.
Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects.
Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity.
In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC
and C
from 0.7to6.0 mg JY09. The half-life of JY09 was ~9.3 days, and the peak concentration was reached at ~60-72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies.
JY09 has a long half-life of ~9.3 days, with an acceptable safety profile.
JY09 has a long half-life of ~ 9.3 days, with an acceptable safety profile.
Memantine is currently the only drug that acts on the glutamate energy system to treat Alzheimer's disease. A generic memantine tablet was developed to offer an alternative to the marketed tablet formulation. The purpose of this study was to assess the bioequivalence of two different memantine formulations among healthy male Chinese subjects under fasting and fed conditions.
We carried out single-center, randomized, single-dose, open-label, two-period, cross-over studies which including 20 healthy male Chinese subjects under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 240hours after dosing. Key pharmacokinetic parameters including area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC
), area from time zero to infinite (AUC
), and C
were used for bioequivalence assessment.
Under fasting condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 106.5 - 114.0% for C
, 99.4 - 107.9% for AUC
, and 100.0 - 109.6% for AUC
. Under fed condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 94.8 - 104.3% for C
, 98.2 - 110.5% for AUC
, and 99.2 - 113.0% for AUC
.
The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The aim of the study was to evaluate the efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, and a meta-analysis was performed using randomized controlled trials (RCTs).
We searched studies published on PubMed, Cochrane Central Register of Controlled Trials, and Embase to collect RCTs comparing etelcalcetide with placebo for the treatment of SHPT. https://www.selleckchem.com/products/tl12-186.html Unpublished studies and information were also searched in ClinicalTrials.
Five RCTs involving 1,268 participants were eligible for inclusion in this meta-analysis. Compared with placebo, etelcalcetide contributed to more participants who achieved ≥30% reduction in parathyroid hormone (PTH) (relative risk (RR) 8.64; 95% CI, 6.66 to 11.19; p < 0.00001) and a PTH level of ≤300 pg/mL (RR 11.80; 95% CI, 8.15 to 17.08; p < 0.00001) as well as an increase in the incidence of hypocalcemia (RR 18.76; 95% CI, 4.55 to 77.26, p < 0.0001), nausea (RR 1.79; 95% CI, 1.19 to 2.70; p = 0.00h SHPT receiving hemodialysis.
Aim of the study was to investigate soluble Klotho (sKl), fibroblast growth factor 23 (FGF23) concentrations, and their correlations with cardiovascular complications in children with CKD.
38 children with CKD stages 2-5 were compared to 38 healthy controls in terms of plasma FGF23, serum sKl, peripheral and central blood pressure, arterial stiffness (pulse wave velocity - (PWV)), carotid intima media thickness (cIMT), left ventricular mass index (LVMI), and diastolic function. Correlations between FGF23, sKl, and cardiovascular parameters were investigated.
The CKD group was characterized by higher FGF23, lower sKl concentrations, higher peripheral and central blood pressure, arterial stiffness, cIMT, left ventricular mass index, and decreased E/A ratio compared to the control group. In CKD children, sKl correlated negatively with diastolic blood pressure (DBP), mean arterial pressure (MAP), central systolic, diastolic, and mean blood pressure, PWV, and LVMI. In multivariate analysis, higher sKl was a significant predictor of lower peripheral and central DBP and lower LVMI and E/A, whereas higher FGF23 was a predictor of higher of LVMI.
76; 95% confidence interval (95% CI) 0.56-1.01; p=0.06) (heterogeneity I
=34%). We recorded 222 adverse events in 2,742 patients treated with bemiparin and 288 adverse events in 2,731 patients treated with enoxaparin (8.1 vs. 10.5 adverse events per 100 patients, respectively; p=0.003). However, the meta-analysis for safety showed a significant heterogeneity making not possible to pool the result across the trials.
Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.
To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects.
Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity.
In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC
and C
from 0.7to6.0 mg JY09. The half-life of JY09 was ~9.3 days, and the peak concentration was reached at ~60-72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies.
JY09 has a long half-life of ~9.3 days, with an acceptable safety profile.
JY09 has a long half-life of ~ 9.3 days, with an acceptable safety profile.
Memantine is currently the only drug that acts on the glutamate energy system to treat Alzheimer's disease. A generic memantine tablet was developed to offer an alternative to the marketed tablet formulation. The purpose of this study was to assess the bioequivalence of two different memantine formulations among healthy male Chinese subjects under fasting and fed conditions.
We carried out single-center, randomized, single-dose, open-label, two-period, cross-over studies which including 20 healthy male Chinese subjects under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 240hours after dosing. Key pharmacokinetic parameters including area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC
), area from time zero to infinite (AUC
), and C
were used for bioequivalence assessment.
Under fasting condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 106.5 - 114.0% for C
, 99.4 - 107.9% for AUC
, and 100.0 - 109.6% for AUC
. Under fed condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 94.8 - 104.3% for C
, 98.2 - 110.5% for AUC
, and 99.2 - 113.0% for AUC
.
The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).
The aim of the study was to evaluate the efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, and a meta-analysis was performed using randomized controlled trials (RCTs).
We searched studies published on PubMed, Cochrane Central Register of Controlled Trials, and Embase to collect RCTs comparing etelcalcetide with placebo for the treatment of SHPT. https://www.selleckchem.com/products/tl12-186.html Unpublished studies and information were also searched in ClinicalTrials.
Five RCTs involving 1,268 participants were eligible for inclusion in this meta-analysis. Compared with placebo, etelcalcetide contributed to more participants who achieved ≥30% reduction in parathyroid hormone (PTH) (relative risk (RR) 8.64; 95% CI, 6.66 to 11.19; p < 0.00001) and a PTH level of ≤300 pg/mL (RR 11.80; 95% CI, 8.15 to 17.08; p < 0.00001) as well as an increase in the incidence of hypocalcemia (RR 18.76; 95% CI, 4.55 to 77.26, p < 0.0001), nausea (RR 1.79; 95% CI, 1.19 to 2.70; p = 0.00h SHPT receiving hemodialysis.
Aim of the study was to investigate soluble Klotho (sKl), fibroblast growth factor 23 (FGF23) concentrations, and their correlations with cardiovascular complications in children with CKD.
38 children with CKD stages 2-5 were compared to 38 healthy controls in terms of plasma FGF23, serum sKl, peripheral and central blood pressure, arterial stiffness (pulse wave velocity - (PWV)), carotid intima media thickness (cIMT), left ventricular mass index (LVMI), and diastolic function. Correlations between FGF23, sKl, and cardiovascular parameters were investigated.
The CKD group was characterized by higher FGF23, lower sKl concentrations, higher peripheral and central blood pressure, arterial stiffness, cIMT, left ventricular mass index, and decreased E/A ratio compared to the control group. In CKD children, sKl correlated negatively with diastolic blood pressure (DBP), mean arterial pressure (MAP), central systolic, diastolic, and mean blood pressure, PWV, and LVMI. In multivariate analysis, higher sKl was a significant predictor of lower peripheral and central DBP and lower LVMI and E/A, whereas higher FGF23 was a predictor of higher of LVMI.
0 Comentários
0 Compartilhamentos
88 Visualizações
0 Anterior
