BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg and 40 mg tablet (Yuhan, Pharmaceutical Corp. Seoul, Korea) as test drugs and Olmetec(R) 20 mg and 40 mg tablet (Daewoong, Pharmaceutical Corp. Seoul, Korea) as reference drugs. Second objective of this study was to evaluate the dose-proportionality of two formulations. METHODS: Two studies (20 mg, 40 mg) were conducted as a randomized, open-label, 2-period, crossover design. Each subject received one 20 mg or 40 mg tablet of the reference or test formulation of olmesartan medoxomil in each study. Blood samples were obtained during the 48-hour period after the dose in each treatment period. Wash-out period was 1 week in each study. Concentrations of olmesartan medoxomil in plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection (LC/MS/MS). The primary pharmacokinetic parameters were Cmax (maximum concentration) and AUCt (area under the concentration-time curve from time 0 to the last sampling time). RESULTS: A total number of 40 healthy male volunteers participated in the study and 37 volunteers completed both treatment periods in 20 mg trial. All 40 participants completed both treatment periods in 40 mg trial. The 90 % CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug) were 0.93 ~ 1.04 for AUCt and 0.97 ~ 1.08 for Cmax in 20 mg trial. The 90 CIs were 0.94 ~ 1.02 for AUCt and 1.00 ~ 1.11 for Cmax in 40 mg trial. All parameters of two studies satisfy the range of bioequivalence criterion. CONCLUSION: The obtained results indicated that pharmacokinetic exposure to Olmesartan 20 mg and 40 mg tablet was bioequivalent to that of Olmetec(R) 20 mg and 40 mg tablet, respectively.
Chromatography, Liquid ; Cross-Over Studies ; Humans ; Hypertension ; Imidazoles ; Male ; Plasma ; Receptors, Angiotensin ; Tetrazoles ; Therapeutic Equivalency

BACKGROUND: Many Studies regarding hemodynamic changes by various vasodilators, such as nitroprusside, nifedipine, and hydralazine have been reported, however little data are available upon acute hemodynamic change due to captopril, an angiotensin converting enzyme inhibitor especially in chronic regurgitant valvular heart disease. Therefore the aim of this study is to evaluate the acute hemodynamic effects of sublingual captopril in patients with regurgitant valvular heart diseases. METHODS: Among the 9 patients enrolled in this study, 5 patients mitral regurgitation, 2 had aortic regurgitation, and 2 had both. Five had patients were male and 4 were female. Before, 15 minutes and 30 minutes after administration of 25mg of captopril via sublingual route, forward cardiac output was measured three times using Swan-Ganz catheter. Right and left cardiac catheterization were also done at each phase and measurement of pulmonary capillary wedge pressures, pulmonary artery pressures, right atrial pressures, aortic pressures, left ventricular pressures were done. RESULTS: 1) Heart rate, pulmonary capillary wedge pressures, cardiac output and cardiac indices left ventricular end-diastolic pressure, diastolic and mean aortic pressures, and diastolic pulmonary artery pressure showed no significant change after administration of sublingual captopril. 2) Systolic aortic pressure decreased significantly from basal value(130+/-35) to 15 minute value(126+/-39). 3) Systemic vascular resistance at 15 minute showed significant reduction as compared with basal value(from 1743+/-551 to 1642+/-491). Pulmonary vascular resistance at 30 minutes(254+/-193) was significantly lower than basal value(282+/-229). CONCLUSIONS: Reductions of systemic and pulmonary vascular resistance occurred relatively rapidly, however, acute effects on cardiac output and pulmonary capillary wedge pressures were not evident. Clinical implication of sublingual captopril in patients with regurgitant valvular heart diseases is worth evaluationg by more extensive hemodynamic studies.
Aortic Valve Insufficiency ; Arterial Pressure ; Arteries ; Atrial Pressure ; Blood Pressure ; Capillaries ; Captopril* ; Cardiac Catheterization ; Cardiac Catheters ; Cardiac Output ; Catheters ; Female ; Heart Rate ; Heart Valve Diseases* ; Hemodynamics* ; Humans ; Hydralazine ; Male ; Mitral Valve Insufficiency ; Nifedipine ; Nitroprusside ; Peptidyl-Dipeptidase A ; Pulmonary Artery ; Pulmonary Wedge Pressure ; Vascular Resistance ; Vasodilator Agents ; Ventricular Pressure

Breast carcinoma is common malignancy in women and frequently metastasize to multiple organ such as lung, bone, lymph node and liver. But metastasis to gastrointestinal tract is rare and only two cases have been reported in Korea. We experienced a case of upper gastrointestinal bleeding caused by gastric metastasis from ductal carcinoma of breast and report this case with review of several literatures.
Breast Neoplasms* ; Breast* ; Carcinoma, Ductal ; Female ; Gastrointestinal Tract ; Hemorrhage* ; Humans ; Korea ; Liver ; Lung ; Lymph Nodes ; Neoplasm Metastasis*