Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
Completed
IPCA Laboratories Ltd.
Phase 1
2012-10-01
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, cross over 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.
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
Completed
IPCA Laboratories Ltd.
Phase 1
2012-10-01
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, cross over 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.
Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
Completed
Centre Hospitalier Universitaire de Saint Etienne
Phase 4
2015-06-11
Despite a large diffusion for generic anti-hypertensive, they are not currently used.
Clinical validation studies could be better to convince users and prescribers than
pharmacologic validation only.
A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place
in real conditions of care for hypertensive patients, for a manometer control criteria.
The aim of the study is to test the hypothesis of non-inferiority for generic
anti-hypertensive for blood pressure control.
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