Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
Terminated
NHS Greater Glasgow and Clyde
Phase 2
2005-03-01
The principal research objectives are to demonstrate cardioselective beta-blockade using
bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality
of life in patients with heart failure and coexistent moderate or severe chronic obstructive
pulmonary disease with or without significant reversibility. Patients will be followed up for
4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated
dose. Health status will be assessed using a generic and two disease specific questionnaires,
and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise
testing.
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition
Completed
IPCA Laboratories Ltd.
Phase 1
2012-08-01
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
between Test Product and the corresponding Reference Product under fasting condition in
normal, healthy, adult human subjects.
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
Completed
IPCA Laboratories Ltd.
Phase 1
2012-08-01
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
between Test Product and the corresponding Reference Product under fed condition in normal,
healthy, adult human subjects.
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