Who is sponsoring NCT02417246?

NCT02417246 is sponsored by University of Florida.

What condition does NCT02417246 study?

NCT02417246 studies Blood Pressure.

What drugs are being tested in NCT02417246?

Interventions: brand name metoprolol ER, Generic A, Generic B.

What is the status of NCT02417246?

NCT02417246 is currently COMPLETED.

Last reviewed 2020-02-06 · How we verify

Open-Labeled Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Metoprolol ER

NCT02417246 Phase 4 COMPLETED Results posted

Recently, the quality of generic metoprolol extended-release (ER) products has been called into question with reports of inconsistent effects when switching from the brand name product to a generic formulation. Problems with how the body processes these drugs could have serious and widespread consequences given the high frequency of metoprolol ER use in the management of various cardiovascular disorders, including high blood pressure, coronary heart disease, heart failure, and cardiac arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead to variability in the way the body breaks down the drug (pharmacokinetics) and clinical response to generic versus name brand metoprolol ER formulations. Investigators will study the brand name and generic metoprolol ER formulations in subjects with high blood pressure to compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses of each product (brand name and two approved generics). The study objective is to provide information on how the body breaks down generic and brand name metoprolol ER products (pharmacokinetics) and how the body responds to generic and brand name metoprolol ER products (pharmacodynamics) to better understand if generic metoprolol ER products are as good as the brand name product.

Details

Lead sponsor	University of Florida
Phase	Phase 4
Status	COMPLETED
Enrolment	61
Start date	2015-08
Completion	2018-06-06

Conditions

Blood Pressure

Interventions

brand name metoprolol ER
Generic A
Generic B

Primary outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC) — 0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dose
The AUC of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and standard deviation (SD) values of AUC are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.
Peak Plasma Concentration (Cmax) of Metoprolol Succinate — 0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dose
The Peak Plasma Concentration (Cmax) of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and SD values of Cmax are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.

Countries

United States