48 completed, 2 terminated, 1 unknown, 1 withdrawn. 17 Phase 3, 10 Phase 1, 8 Phase 2, 3 Phase 4, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 17 |
| Phase 1 | 10 | Completed 9, Unknown 1 |
| Phase 2 | 8 | Completed 7, Withdrawn 1 |
| Phase 4 | 3 | Completed 2, Terminated 1 |
| Not applicable | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM - HIV-associated Tuberculosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 30 | 2024-02-13 | 2026-07-20 |
| Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease Formoterol A, Formoterol B (placebo) - Alzheimer's Disease, Cognitive Dysfunction | Phase 2 | Withdrawn | Palo Alto Veterans Institute for Research | 2023-01-01 | 2020-09-16 | |
| Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity Humira 40 MG in Prefilled Syringe, Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe - Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis | Phase 3 | Completed | Biocon Biologics Inc. | 374 | 2022-11-21 | 2024-10-22 |
| Study to Evaluate the Effectiveness of Legalon® Legalon® 140 mg - Non-alcoholic Fatty Liver Disease (NAFLD) | Completed | Mylan Inc. | 362 | 2022-08-08 | 2025-09-30 | |
| Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients Dymista - Allergic Rhinitis | Completed | Mylan Inc. | 924 | 2021-10-27 | 2023-11-13 | |
| Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles MR-100A-01 - Contraception | Phase 3 | Completed | Mylan Technologies Inc. | 1320 | 2021-10-26 | 2026-09-14 |
| Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg) abacavir, dolutegravir and lamivudine dispersible tablets, Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine - HIV-1-infection | Early Phase 1 | Completed | Mylan Inc. | 43 | 2021-08-01 | 2022-03-25 |
| Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis Pimecrolimus 1% Top Cream - Atopic Dermatitis | Completed | Mylan Inc. | 130 | 2021-03-18 | 2023-05-24 | |
| Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical Hypercholesterolemia | Completed | Mylan Inc. | 259 | 2020-12-08 | 2023-11-07 | |
| Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain MR-107A-01, Placebo - Pain, Postoperative Pain | Phase 2 | Completed | Mylan Inc. | 114 | 2020-09-29 | 2022-08-08 |
| Mylan Insulin Aspart Study MYL-1601D Product, FlexPen NovoLog® - Diabetes Mellitus, Type 1 | Phase 3 | Completed | Mylan Inc. | 478 | 2018-11-07 | 2022-02-25 |
| Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules Placebo, Tobi Podhaler - Cystic Fibrosis | Phase 4 | Completed | Mylan Inc. | 47 | 2018-06-26 | 2022-03-03 |
| A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD Revefenacin, Placebo, Formoterol - Chronic Obstructive Pulmonary Disease (COPD) | Phase 3 | Completed | Mylan Inc. | 122 | 2018-05-31 | 2022-02-24 |
| Mylan Insulin Glargine Study MYL-1501D product using manufacture process V, MYL-1501D product using manufacture process VI - Diabetes Mellitus, Type 1 | Phase 3 | Completed | Mylan Inc. | 219 | 2017-11-29 | 2022-03-03 |
| Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD Revefenacin, Spiriva Handihaler®, Placebo for Revefenacin - Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR) | Phase 3 | Completed | Mylan Inc. | 207 | 2017-03-27 | 2022-02-24 |
| Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid Efavirenz, tenofovir /emtricitabine, tenofovir/lamivudine - HIV | Phase 1 | Unknown | St Stephens Aids Trust | 35 | 2016-11-21 | 2017-06-21 |
| Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects M834, US-Sourced Orencia®, EU-Sourced Orencia® - Healthy Volunteers | Phase 1 | Completed | Momenta Pharmaceuticals, Inc. | 243 | 2016-10-01 | 2017-10-24 |
| A Survey on Efficacy and Safety in Patients With Endometriosis Dydrogesterone - Endometriosis | Completed | Mylan Inc. | 60 | 2016-08-23 | 2022-07-06 | |
| Thorough QT (TQT) Study of TD-4208 in Healthy Subjects TD-4208 175 mcg, TD-4208 700 mcg, Placebo for TD-4208 - Cardiac Repolarization in Healthy Subjects | Phase 1 | Completed | Mylan Inc. | 48 | 2016-05-01 | 2022-02-24 |
| Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Econazole Nitrate Cream, 1%, Placebo - Tinea Pedis | Phase 3 | Completed | Mylan Inc. | 876 | 2016-03-15 | 2022-03-07 |
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Pulmonary Disease, Chronic Obstructive (10) · Diabetes Mellitus, Type 1 (4) · Pain (3) · Breast Neoplasms (2) · Cystic Fibrosis (2) · Dermatitis, Atopic (2) · Digestive System Diseases (2) · Exocrine Pancreatic Insufficiency (2) · Pancreatic Diseases (2) · Acute Pain (1) · Alzheimer Disease (1) · Arthritis, Psoriatic (1) · Bronchitis, Chronic (1) · Burns (1) · Chemotherapy-Induced Febrile Neutropenia (1)
revefenacin (13) · Adalimumab (3) · Insulin Glargine (3) · Lamivudine (3) · Emtricitabine (2) · Granulocyte Colony-Stimulating Factor (2) · MYL-1401H (2) · Tenofovir (2) · Tiotropium Bromide (2) · dolutegravir (2) · efavirenz (2) · lamivudine, zidovudine drug combination (2) · pegfilgrastim (2) · pimecrolimus (2) · Abatacept (1)
United States (25) · Germany (5) · Hungary (5) · Bulgaria (4) · Canada (4) · Estonia (4) · Japan (4) · Slovakia (4) · South Africa (4) · Thailand (4) · United Kingdom (4) · Czechia (3) · Latvia (3) · Poland (3) · Ukraine (3)
Fausto Berti (2) · Marta Boffito, MBBS,MD,PhD (2) · Thomas Blevins, MD (2) · Abhijit Barve, MD (1) · Ahmad Salehi, M.D.,Ph.D. (1) · Alisia Sachse, MD (1) · Candida Fratazzi, MD (1) · Eduardo Pennella, MD (1) · Eric Davis, MD (1) · James Bush, MBChB, PhD, MRCS(Ed), MFPM (1) · Jo Kitawaki, MD., PhD. (1) · Jun Kato, MD., Ph.D. (1) · Jun Kato, MD.,Ph.D. (1) · Kathrivel Subramaniam, MD (1)
PMID 33124005, PMID 31632000, PMID 32343967, PMID 32393215, PMID 34174848, PMID 36681255, PMID 38560416, PMID 27918780, PMID 28987804, PMID 29096627, PMID 30084943, PMID 30824956, PMID 31150963, PMID 31647854, PMID 31666076, PMID 32247539, PMID 33866430, PMID 34125340, PMID 34262403, PMID 36114990, PMID 39429809, PMID 40493334, PMID 41993723
2014 (5)