Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers

2017 ◽  
Vol 7 (4) ◽  
pp. 422-434
Author(s):  
Olivia Burns ◽  
John Zhu ◽  
Michael J Manyak ◽  
Ramiya Ravindranath ◽  
Fariba Koosha ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Relative Bioavailability ◽  
Fixed Dose ◽  
Healthy Male ◽  
Healthy Male Volunteers ◽  
Male Volunteers

Safety and Tolerance of Intravenous Nimodipine

1994 ◽  
Vol 28 (10) ◽  
pp. 1143-1148 ◽  
Author(s):  
John J. Sramek ◽  
Allen H. Heller ◽  
Pavur R. Sundaresan ◽  
John Lettieri ◽  
Suzanne Sawin ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Normal Population ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Healthy Male ◽  
Peripheral Vein ◽  
Double Blind ◽  
Healthy Male Volunteers ◽  
Male Volunteers

OBJECTIVE: To evaluate the safety and tolerance of intravenous nimodipine administered via a peripheral vein in healthy male volunteers. DESIGN: Double-blind, placebo- and vehicle-controlled trial with three fixed-dose panels. SETTING: Inpatient infusion and observation periods. SUBJECTS: 61 healthy male volunteers, aged 18–40 years. METHODS: Subjects in panel 1 received nimodipine 0.4 mg/h, vehicle 2 mL/h, or placebo 2 mL/h; subjects in panel 2 received nimodipine 1 mg/h, vehicle 5 mL/h, or placebo 5 mL/h; subjects in panel 3 received nimodipine 2 mg/h, vehicle 10 mL/h, or placebo 10 mL/h. All infusions were administered intravenously for 48 hours and volunteers were observed for 48 hours after cessation of the infusion. In addition to standard safety assessments (physical examination, electrocardiogram, laboratory studies, and adverse event reporting), supine and standing blood pressures and pulse rates were measured frequently. Plasma samples were also analyzed for nimodipine and its two demethylated metabolites. RESULTS: Of 61 subjects, 55 completed the 48-hour infusion and 6 discontinued the study because of adverse events. Intravenous nimodipine was well tolerated at 0.4 and 1 mg/h. However, all six subjects who received nimodipine 2 mg/h experienced moderate-to-severe adverse events, and one subject was discontinued because of dizziness, diaphoresis, and postural hypotension. The matched vehicle (10 mL/h) also was not well tolerated, with three subjects who discontinued because of phlebitis. Two subjects who received placebo were also discontinued during the study. Small (2 mm Hg) decreases in mean supine diastolic blood pressure were observed in the 0.4- and 1-mg/h nimodipine groups, but the 2-mg/h group showed a slight (5 mm Hg) increase in blood pressure. These changes were not clinically significant. Clearance and half-life of nimodipine and its metabolites were similar at all three dosages. CONCLUSIONS: Using peripheral vein administration, nimodipine 2 mg/h and matched vehicle at 10 mL/h were not well tolerated in this healthy normal population. The maximum tolerated dose of nimodipine was found to be 1 mg/h.

Glucocorticoid treatment is associated with dose-dependent insulin resistance in healthy male volunteers

2019 ◽  
Author(s):  
Riccardo Pofi ◽  
Ilaria Bonaventura ◽  
Nanthia Othonos ◽  
Thomas Marjot ◽  
Ahmed Moolla ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Healthy Male ◽  
Glucocorticoid Treatment ◽  
Healthy Male Volunteers ◽  
Male Volunteers ◽  
Dose Dependent
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