Clinical trials: sponsored by Sun Pharmaceutical Industries Limited
Blepharitis
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
- Trial name
- DOUBle (NCT01408082)
- Testing
- ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined), Azasite, Dexamethasone
- Where
- 45 sites in United States
- Volunteers
- 917 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Ocular Inflammation
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in…
- Trial name
- NCT01190878
- Testing
- ISV-303, DuraSite Vehicle, Xibrom™
- Volunteers
- 169 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Dry Eye Disease
A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease
The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.
- Trial name
- ISV-101 (NCT01478555)
- Testing
- ISV 101
- Sponsor
- Sun Pharmaceutical Industries Limited
Active, Symptomatic Blepharitis
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.
- Trial name
- ISV-305 (NCT01543490)
- Testing
- ISV-305, Vehicle
- Where
- United States
- Volunteers
- 558 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Ocular Inflammation
Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.
- Trial name
- ISV-303 (NCT01576952)
- Testing
- ISV-303, DuraSite Vehicle
- Volunteers
- 268 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Metastatic Prostate Cancer
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).
- Trial name
- NCT02962284
- Testing
- abiraterone acetate with Methylprednisolone
- Volunteers
- 20 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Inflammation and Pain Associated With Cataract Surgery
Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.
- Trial name
- ISV-305 (NCT03192137)
- Testing
- ISV-305, Vehicle
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Cataract
Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
- Trial name
- NCT01387464
- Testing
- ISV-303, Bromday™
- Volunteers
- 60 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Active Rheumatoid Arthritis
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
- Trial name
- NCT02534896
- Testing
- Treatment I, Treatment II, Treatment III
- Where
- 20 sites in Belgium, Netherlands
- Volunteers
- 150 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Oral Mucositis, Stomatitis
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.
- Trial name
- NCT01288625
- Testing
- Amifostine
- Sponsor
- Sun Pharmaceutical Industries Limited
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Efficacy and Safety Study of SUNPG1622
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
- Trial name
- NCT02980705
- Testing
- SUNPG1622 I dose
- Where
- 4 sites in United States, Hungary and 2 more
- Volunteers
- 180 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Plaque Psoriasis
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult…
- Trial name
- NCT03298581
- Testing
- Halobetasol Propionate
- Sponsor
- Sun Pharmaceutical Industries Limited
Schizophrenia, Bipolar Disorder
Bio-equivalence Study Between SAPHRIS and Asenapine
This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.
- Trial name
- ASN (NCT01948024)
- Testing
- SAPHRIS, Asenapine
- Where
- 7 sites in United States
- Volunteers
- 65 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Asthma
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory…
- Trial name
- NCT03528577
- Testing
- Zero-dose, 90 mcg of PROAIR® HFA, 180 mcg of 90 mcg of PROAIR® HFA
- Where
- 8 sites in United States
- Volunteers
- 128 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Contraception
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol.
- Trial name
- NCT01699022
- Testing
- Injection Cyclofem
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries Limited
Type 2 Diabetes Mellitus
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033
- Trial name
- NCT01406717
- Testing
- SPIL1033
- Where
- 34 sites in India
- Volunteers
- 360 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Atopic Dermatitis
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult…
- Trial name
- NCT03245385
- Testing
- Treatment with Halobetasol propionate 0.05% topical spray
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Vulvar Atrophy, Vaginal Atrophy
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is…
- Trial name
- NCT01753102
- Testing
- Estradiol
- Where
- India
- Volunteers
- 49 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Infertility
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial.
- Trial name
- NCT00610077
- Testing
- Letrozole, Clomiphene citrate
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Sun Pharmaceutical Industries Limited