100 completed, 1 terminated. 82 Not applicable, 11 Phase 1, 6 Early Phase 1, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 82 | Completed 82 |
| Phase 1 | 11 | Completed 11 |
| Early Phase 1 | 6 | Completed 6 |
| Phase 3 | 1 | Terminated 1 |
| Phase 4 | 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 |
|---|---|---|---|---|---|---|
| Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate Fluticasone / Salmeterol, Placebo, Advair Diskus 100/50 - Asthma | Not applicable | Completed | Roxane Laboratories | 1430 | 2014-08-01 | 2018-01-23 |
| A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain Codeine - Pain | Phase 3 | Terminated | Roxane Laboratories | 31 | 2012-04-01 | 2018-10-02 |
| Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects Morphine Sulfate - Pain | Phase 4 | Completed | Roxane Laboratories | 50 | 2011-04-01 | 2018-02-05 |
| Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions Tinidazole - Trichomoniasis | Phase 1 | Completed | Roxane Laboratories | 28 | 2009-09-01 | 2018-01-23 |
| Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions Oxcarbazepine - Seizures | Phase 1 | Completed | Roxane Laboratories | 59 | 2009-09-01 | 2018-01-23 |
| Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions Oxcarbazepine - Seizures | Phase 1 | Completed | Roxane Laboratories | 64 | 2009-09-01 | 2018-01-23 |
| Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions Cevimeline - Dry Mouth | Early Phase 1 | Completed | Roxane Laboratories | 26 | 2009-02-01 | 2018-01-23 |
| Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions Cevimeline - Dry Mouth | Early Phase 1 | Completed | Roxane Laboratories | 27 | 2009-02-01 | 2018-01-23 |
| Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions Imipramine Pamoate - Depression | Not applicable | Completed | Roxane Laboratories | 39 | 2008-08-01 | 2018-02-05 |
| Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions Montelukast, Singulair - Asthma | Early Phase 1 | Completed | Roxane Laboratories | 35 | 2008-08-01 | 2018-01-23 |
| Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions Montelukast, Singulair - Asthma | Early Phase 1 | Completed | Roxane Laboratories | 36 | 2008-08-01 | 2018-01-23 |
| Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions Oxymorphone - Pain | Phase 1 | Completed | Roxane Laboratories | 42 | 2008-06-01 | 2018-01-23 |
| Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions letrozole - Breast Cancer | Phase 1 | Completed | Roxane Laboratories | 28 | 2008-03-01 | 2018-01-23 |
| Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions Letrozole - Breast Cancer | Phase 1 | Completed | Roxane Laboratories | 28 | 2008-03-01 | 2018-01-23 |
| Dose Linearity Study of Codeine Sulfate Under Fasted Conditions Codeine Sulfate - Pain | Phase 1 | Completed | Roxane Laboratories | 34 | 2008-03-01 | 2018-01-23 |
| Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions Montelukast, Singulair - Asthma | Early Phase 1 | Completed | Roxane Laboratories | 34 | 2008-02-01 | 2018-01-23 |
| Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions Montelukast, Singulair - Asthma | Early Phase 1 | Completed | Roxane Laboratories | 35 | 2008-02-01 | 2018-01-23 |
| Food Effect Study of Codeine Sulfate Codeine Sulfate - Pain | Phase 1 | Completed | Roxane Laboratories | 36 | 2008-01-01 | 2018-01-23 |
| Comparative Bioavailability Study of Codeine Sulfate Codeine Sulfate - Pain | Phase 1 | Completed | Roxane Laboratories | 34 | 2008-01-01 | 2018-01-23 |
| Steady State Study of Codeine Sulfate Codeine Sulfate - Pain | Phase 1 | Completed | Roxane Laboratories | 34 | 2008-01-01 | 2018-01-23 |
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Hypertension (12) · Pain (11) · Seizures (9) · Breast Neoplasms (7) · Xerostomia (6) · Asthma (5) · Bipolar Disorder (4) · Depression (4) · HIV Infections (4) · Epilepsy (3) · Angina Pectoris, Variant (2) · Angina, Stable (2) · Colitis, Ulcerative (2) · Edema (2) · Essential Hypertension (2)
O(6)-codeine methyl ether (5) · Oxcarbazepine (5) · Irbesartan (4) · Levetiracetam (4) · Lithium (4) · Morphine (4) · Mycophenolic Acid (4) · Pilocarpine (4) · montelukast (4) · Quetiapine Fumarate (3) · Zidovudine (3) · exemestane (3) · Amlodipine (2) · Anastrozole (2) · Cilostazol (2)
United States (95) · Canada (4)
Daniel V Freeland, DO (8) · Soran Hong, MD (6) · Alan K Copa, PharmD (5) · Daniel V Freeland, D.O. (4) · Jolene K Berg, MD (4) · Alan Copa, PharmD (3) · Dennis Morrison, D.O. (3) · Dennis Morrison, DO (3) · Dennis N Morrison, D.O. (3) · So Ran Hong, M.D. (3) · Steven Herrmann, MD (3) · Alan K Copa (2) · Benoit Girard, MD (2) · Cynthia Zamora, MD (2) · Darin Brimhall, DO (2)