Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition
HealthyThe purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
HealthyAn open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
HypertensionThe purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
InfectionThe objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
InsomniaThe objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
HerpesThe objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fed conditions.
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor...
InfantVery Low Birth Weight4 moreThis study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children). PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN). SECONDARY ENDPOINT: To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants; To compare growth and nutritional status of the 2 groups by randomized arm. To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed. To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding). DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months. INCLUSION CRITERIA Weight at birth ranging: 700 - 1501 grams; Gestational age up to 25 weeks and 6 days; Written informed consent from parents or guardians EXCLUSION CRITERIA Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract) Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC) Pre-existing cutaneous disease not allowing the placement of the probe
Calcium and Vitamin D Malnutrition in Elderly Women
OsteoporosisSecondary HyperparathyroidismThis study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age. A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets. A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition
KwashiorkorMarasmusThe need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial. This study will compare the recovery rates of children with SAM treated at home with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their outpatient case management. The investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride...
DepressionTo demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.