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List of Trials


Title: A multicenter, open-label, randomised, two-treatment, twosequence, cross-over, steady-state clinical bioequivalence study of Felbamate 600 mg tablet of Lannett Company Inc., USA with Felbatol® 600mg tablet of Meda Pharmaceutical Inc., USA in Adult Epileptic (Partial Seizures with and without generalization) patients already established (Run-In) on Felbamate as an adjunctive therapy under fasting state.
Study No. PR/BE/13/287
Prinicipal Investigator: Dr. Sunit Shah, MD, DM (Neurology)
Date of Presentation: 12 April 2014


Title: Phase III study entitled "Efficacy and Tolerability of Pregabalin OD in treatment of Neuropathic pain-Arandomised ,double blind, Comparative study (Version No. 1 dated 06.08.2007 supercede nil)
Study No. R1PREGA073014
Prinicipal Investigator: Dr. Sunit Shah, MD, DM (Neurology)


Title: Randomized, Comparative, Phase III Clinical Trial to Compare the Efficacy and Safety of Recombinant human Pegylated Granulocyte Colony Stimulating Factor (Peg G-CSF) Versus Granulocyte Colony Stimulating Factor (G-CSF) in Subjects with Nonmyeloid Malignancies Receiving Myelosuppressive Chemotherapy


H9B-MC-BCDM: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy.


H9B-MC-BCDO: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.


H9B-MC-BCDP: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA).


Fighting cervical cancer, FOGSI cervical cancer registry, a reaching the unreached FOGSI initiative 2010. A pap smear & HPV DNA & colposcopy based study.


Study No. - PT-101: Phase 1 Study of Intravaginal Tamoxifen (PT-101): Randomized, double blind study of safety, pharmacokinetic (PK) and pharmacodynamics (PD) in menopausal patients with moderate to severe Vulvar and vaginal atrophy.


Title: Randomized, Comparative, Phase III Clinical Trial to Compare the Efficacy and Safety of Recombinant human Pegylated Granulocyte Colony Stimulating Factor (Peg G-CSF) Versus Granulocyte Colony Stimulating Factor (G-CSF) in Subjects with Nonmyeloid Malignancies Receiving Myelosuppressive Chemotherapy.


A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Dr. Reddy's Laboratories., India) to the reference listed drug Xeloda® (Capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in Metastatic Breast Cancer or Colorectal Cancer patients under fed condition.


A Multicenter, Open-Label, Randomized, Parallel-Group, Comparative Study To Evaluate Efficacy, Safety and Tolerability of Fixed Dose Combination of Azelastine and Mometasone Nasal Spray Compared to Azelastine Nasal Spray and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis.


A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Repaglinide / Metformin IR Tablet Compared with Metformin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.


A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric, Parallel group Study Between Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation CFC Free 100+50mcg/actuation and HFA Propelled pMDI Salbutamol 100 mcg + Beclometasone 50mcg (Clenil Compositum ®HFA spray) in Patients With Stable Persistent Asthma.


A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women with Osteoporosis.


A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric Study Between Budesonide 200 µg in HFA propelled MDI And Beclomethasone Dipropionate 250 µg in HFA propelled MDI (Clenil® HFA 250 µg Spray) in a 12-week Treatment Period of Patients With Stable Persistent Asthma.


A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.