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Top Pharmaceutical Companies in Japan Clinical Trials

13:11 EDT 29th September 2016 | BioPortfolio

PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union (EU) for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in...

Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma

This study evaluates the non-inferiority of the new transdermal patch dosage form containing loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet - Daiichi-Sankyo) for the treatment of acute traumatic injuries.

Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions

This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to heal...

To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

The purpose of the study is to provide access to continued treatment for subjects who participated in other Astellas sponsored ASP2215 trials and for whom the Investigator feels the subject may benefit from continued treatment.

A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)

AMEVIVE® Pregnancy Registry

This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects. The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas P...

Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.

Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.

Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg

The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fasting conditions.

Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg

The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fed conditions.

Cilostazol 50 mg Tablets Under Fasting Conditions

This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg tablet) i...

To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Validation of a Real-Time Urodynamic Measure of Urinary Urgency

Evaluating the effect of VesicareR 10 mg (Solifenacin, Astellas Inc) QD, on the urgency level as recorded by the filling phase of urodynamic testing, in patients with overactive bladder. In this pilot study, 10 patients with overactive bladder syndrome (OAB) symptoms and who have previously undergone urodynamic testing which demonstrated detrusor overactivity and who are n...

Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fasting conditions.

Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition

The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.

Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition

The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.

Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fasting Condition

The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.

Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.

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