The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following: Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve. Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.
A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Extended release tablet, 200mg once daily for 4 days
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
Pharmacokinetic profile in terms of Cmax, Cmin, AUC
Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
Time frame: Treatment duration: 4 days
Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)
Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
Time frame: Treatment duration: 4 days
Safety profile in terms of adverse events
Time frame: Treatment duration: 4 days
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