A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
1. Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting
Kyungpook national university
Daegu, Seoul, South Korea
evaluation of pharmacokinetics
The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
Time frame: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
evaluation of safety
* adverse event monitoring * physical examination, vital sign, ECOG, laboratory test
Time frame: from screenig to post-study visit
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