Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)

2017-03-06 18:38:21 | BioPortfolio


An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Rivaroxaban from Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed from: Bayer Healthcare, Germany)


Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.

The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

A comprehensive final report will be issued upon the completion of the study.

Study Design




Repatoxaban, Xarelto


Genuine Research Center GRC




Genuine Research Center, Egypt

Results (where available)

View Results


Published on BioPortfolio: 2017-03-06T18:38:21-0500

Clinical Trials [52 Associated Clinical Trials listed on BioPortfolio]

Patient and Physician Knowledge of Key Safety Messages

This cross-sectional epidemiologic study will measure physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation

The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prop...

Xarelto [SPAF] Post-marketing Surveillance in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. The objective of thi...

Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.

Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the recurrence of thromboembolic event compared to an untreated group in patients with chronic portal vein t...

Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients w...

PubMed Articles [4311 Associated PubMed Articles listed on BioPortfolio]

A case of leukocytoclastic vasculitis caused by novel anticoagulant rivaroxaban.

Cutaneous leukocytoclastic vasculitis (LCV) is type of small vessel vasculitis that commonly presents as palpable purpura involving the lower extremities and buttocks. Approximately half of cases are ...

Effects of a healthy-eater self-schema and nutrition literacy on healthy-eating behaviors among Taiwanese college students.

Unhealthy eating behaviors contribute to obesity and chronic illness. This study examined the relative contributions of a healthy-eater self-schema (a self-conception as a healthy eater) and nutrition...

Healthy China 2030, a breakthrough for improving health.

China has the largest population in the world, and its health levels have greatly affected the healthy development of the population of the world. Healthy China 2030 is a breakthrough for ensuring tha...

An exploration into the cortical reorganisation of the healthy hand in upper-limb complex regional pain syndrome.

Recent evidence demonstrated that complex regional pain syndrome (CRPS) is associated with a larger than normal somatosensory (S1) representation of the healthy hand. The most intuitive mechanism for ...

Healthy diets and a healthy planet.

Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

Dietary patterns which have been found to be important in reducing disease risk.

More From BioPortfolio on "Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)"

Quick Search


Relevant Topics

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Searches Linking to this Trial