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Clinical Trials

CLINICAL TRIALS

Sr. No

Name of Principal Investigator

Project Title

Status

Year

Amount Receive

1

Dr. J D Lakhani

A Randomized, Double Blind, Double Dummy, Comparative, Prospective, Multicenter, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Teneligliptin and Metformin Tablet Compared with Metformin monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Completed

2015-2016

nil

2

Dr. Punit Singh

A multicentre, double blind, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint comparing brinzolamide 1% ophthalmic suspension (manufactured by Indoco remedies ltd., for Watson pharmapvt ltd.), to brinzolamide (azopt®) 1% ophthalmic suspension of Alcon laboratories inc., in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes

Completed

2015-2016

3837005

3

Dr. Dulari Gandhi

A Phase 4/3, Open-Label, Single-Arm, Multicenter Study to Describe the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Adults 50 to 65 Years of Age and in Children 6 to 17 Years of Age in India

Completed

2015-2016

3254586.30

4

Dr. Dulari Gandhi

A Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-PRP-T) Shan5 (with Shantha pertussis) as compared to licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12, and 14-16 Weeks of Age in Healthy Indian Infants

Completed

2015-2016

1886095

5

Dr. KishanNinama

A randomized, double blind, placebo controlled, three arm, parallel group, multi centric, clinical study to evaluate the therapeutic bio-equivalence of two tacrolimus 0.03% topical ointment formulation in adult patients with moderate to severe atopic dermatitis

Ongoing

2017-2018

755020

6

Dr. RashmiMahajan

A Multi-Centre, Randomized, Double Blind, Parallel-Group, Comparative Clinical Trial to evaluate the Safety and Clinical Equivalence of Generic Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) to Clotrimazole Troche /Lozenges ® 10mg (Roxane Laboratories Inc., USA) in subjects with Oropharyngeal Candidiasis

Ongoing

2017-2018

266500

7

Dr KishanNinama

A Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis

Ongoing

2017-2018

81000

8

Dr KishanNinama

A Randomised, Double-blind, Multicentre, Parallel-group, Active & Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g +  Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC® Once Daily 10 mg/g + 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris

2018-2019

Ongoing

81000

9

Dr Arti Shah

A Phase IV, Prospective, Open Label, Non-Comparative, Multicenter Study With 24 Weeks of Treatment Period To Assess Safety, Tolerability And Efficacy of Pirfenidone 200mg Oral Tablets In Patients With Idiopathic Pulmonary Fibrosis (IPF)

2018-2019

Ongoing

81000

10

Dr Chaitri Shah

Randomized, Double blind, Two Arm, Comparative Controlled, Prospective Clinical Trial of Mycobacterium w in Combination with Standard Therapy versus Standard Therapy Alone in Sepsis due to Gram Negative Infection

2017-2018

Ongoing

219867

11

Dr R N Kothari

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

2017-2018

Ongoing

86400

12

Dr R N Kothari

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

2017-2018

Ongoing

54000

13

Dr KishanNinama

A Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis

2017-2018

Ongoing

81000

14

Dr KishanNinama

A Randomised, Double-blind, Multicentre, Parallel-group, Active & Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g +  Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC® Once Daily 10 mg/g + 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris

2018-2019

Ongoing

81000