Advertisement

Topics

Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects

2015-07-21 12:23:23 | BioPortfolio

Summary

Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way cross over, six sequence study to investigate the relative bioavailability of two 75 milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1 [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be randomized, such that approximately 14 evaluable subjects complete the study. Total duration in the study for each subject will be approximately 8 weeks from screening to the follow-up visit.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Cardiovascular Disease

Intervention

Clop F1, Clop F2, Innovator

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-07-21T12:23:23-0400

Clinical Trials [1022 Associated Clinical Trials listed on BioPortfolio]

Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

Purpose: With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients bein...

Neighborhood Environments and Cardiovascular Disease

To investigate the contributions of neighborhood environments to the distribution of cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using data from...

Gene-Environment Interactions in Complex Disease

To assess genetic variation in 87 different cardiovascular disease candidate genes and to measure the associations of these variants with cardiovascular disease and its risk factors.

Cardiovascular Disease Cohort in Guangdong Province

Patients with cardiovascular diseases from Guangdong province will be recruited and followed up for at least 4 years to evaluate the risk factors for cardiovascular-related mortality and d...

Role of Chronic Kidney Disease in Cardiovascular Disease

The purpose of this study is to determine how the progressive loss of kidney function influences cardiovascular disease.

PubMed Articles [17535 Associated PubMed Articles listed on BioPortfolio]

Sex-specific risk factors for cardiovascular disease in women-making cardiovascular disease real.

Sex-specific differences in pathophysiology, prevalence, and impact of cardiovascular disease (CVD) risk factors may explain the high cardiovascular mortality rates in women.

Microbiota-Host Crosstalk: A Bridge Between Cardiovascular Risk Factors, Diet, and Cardiovascular Disease.

Cardiovascular disease is the leading cause of death and is also a major cause of disability worldwide. Indeed, even in well-treated patients for hypertension or dyslipidemia, there is still a high ca...

Plasma tea catechins and risk of cardiovascular disease in middle-aged Japanese subjects: The JPHC study.

Although a potential benefit of drinking green tea has been suggested to reduce the development of cardiovascular disease, no study has investigated the relationship between plasma tea catechin and ri...

Rheumatoid arthritis and risk of cardiovascular disease.

In developing countries, rheumatoid arthritis (RA) remains a seriously under-prioritised disease, particularly among the underprivileged, often resulting in presentation of patients late in the course...

Seasonal Work and Cardiovascular Risk Factors in Farmers.

Cardiovascular disease is the leading cause of death and hospitalization in the rural United States. Midwestern farmers are integral to rural communities, but little is known about the effect of occup...

Medical and Biotech [MESH] Definitions

The co-occurrence of pregnancy and a cardiovascular disease. The disease may precede or follow FERTILIZATION and it may or may not have a deleterious effect on the pregnant woman or FETUS.

Restoration of functions to the maximum degree possible in a person or persons suffering from a CARDIOVASCULAR DISEASE. It also includes cardiac conditioning and SECONDARY PREVENTION in patients with elevated cardiovascular risk profile.

BIOLOGIC PRODUCTS that are imitations but not exact replicas of innovator products.

Processes and properties of the CARDIOVASCULAR SYSTEM as a whole or of any of its parts.

Biological actions and events that support the functions of the CARDIOVASCULAR SYSTEM.

More From BioPortfolio on "Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...


Searches Linking to this Trial