31 completed, 5 terminated. 30 Phase 1, 5 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 30 | Completed 29, Terminated 1 |
| Phase 3 | 5 | Terminated 4, Completed 1 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis pimecrolimus cream 1%, Elidel (pimecrolimus) cream 1%, placebo - Atopic Dermatitis | Phase 3 | Completed | Par Pharmaceutical, Inc. | 582 | 2016-06-01 | 2017-09-29 |
| Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension, CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%), Placebo Sterile Otic Suspension - Otitis Media in Patients With Tympanostomy Tubes | Phase 3 | Terminated | Par Pharmaceutical, Inc. | 203 | 2013-11-01 | 2017-09-26 |
| A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa Ciprofloxacin/Dexamethasone, Ciprodex (R), Placebo - Otitis Externa | Phase 3 | Terminated | Par Pharmaceutical, Inc. | 455 | 2013-07-01 | 2016-10-18 |
| Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension Megestrol acetate concentrated suspension 110 mg/mL, Megestrol acetate concentrated suspension 60 mg/mL, Placebo - Anorexia, Cachexia | Phase 3 | Terminated | Par Pharmaceutical, Inc. | 4 | 2006-06-01 | 2016-05-02 |
| Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients Megestrol acetate concentrated suspension 110 mg/mL, Placebo - Anorexia, Cachexia | Phase 3 | Terminated | Par Pharmaceutical, Inc. | 5 | 2006-06-01 | 2016-06-23 |
| Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension Megestrol acetate concentrated suspension 125 mg/mL - Healthy | Phase 1 | Terminated | Par Pharmaceutical, Inc. | 7 | 2006-05-01 | 2016-10-17 |
| Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions Dronabinol, Marinol - To Determine Bioequivalence Under Fasting Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 69 | 2006-01-01 | 2011-06-27 |
| Bioavailability Study of Propranolol Under Fed Conditions Propranolol, Inderal-LA - To Determine Bioequivalence Under Fed Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 46 | 2005-09-01 | 2017-09-26 |
| Bioavailability Study of Propranolol Under Fasting Conditions Propranolol, Inderal-LA - To Determine Bioequivalence Under Fasting Conditions | Phase 2 | Completed | Par Pharmaceutical, Inc. | 48 | 2005-05-01 | 2008-04-04 |
| Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions Oxandrolone, Oxandrin - To Determine the Bioequivalence Under Fasting Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 26 | 2005-03-01 | 2008-04-04 |
| Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions Tranylcypromine, Parnate - To Determine the Bioavailability of Tranylcypromine | Phase 1 | Completed | Par Pharmaceutical, Inc. | 39 | 2004-10-01 | 2008-04-04 |
| Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions Doxycycline Monohydrate, Monodox - To Determine Bioequivalence Under Fasting Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 36 | 2004-07-01 | 2008-04-04 |
| Bioavailability Study of Clonazepam ODT Under Fasting Conditions Clonazepam, Klonopin Wafers - To Determine Bioequivalence Under Fasting Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 32 | 2004-03-01 | 2008-04-04 |
| Bioavailability Study of Clonazepam Tablets Under Fasting Conditions Clonazepam, Klonopin - To Determine Bioequivalence Under Fasting Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 32 | 2004-02-01 | 2008-04-04 |
| Bioavailability Study of Leflunomide Tablets Under Fed Conditions Leflunomide, ARAVA - To Determine Bioequivalence Under Fed Conditions | Phase 1 | Completed | Par Pharmaceutical, Inc. | 62 | 2003-12-01 | 2017-09-26 |
| Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions Ondansetron, Zofran ODT - Healthy | Phase 1 | Completed | Par Pharmaceutical, Inc. | 24 | 2003-11-01 | 2008-04-16 |
| Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions Ondansetron, Zofran - Healthy | Phase 1 | Completed | Par Pharmaceutical, Inc. | 24 | 2003-10-01 | 2008-04-16 |
| Bioavailability Study of Leflunomide Tablets Under Fasting Conditions Leflunomide, ARAVA - To Determine the Bioequivalence Study Under Fasting | Phase 1 | Completed | Par Pharmaceutical, Inc. | 52 | 2003-06-01 | 2008-04-04 |
| Bioavailability Study of Metronidazole Capsules Under Fed Conditions Metronidazole, Flagyl - To Determine the Bioequivalence Study Under Fed | Phase 1 | Completed | Par Pharmaceutical, Inc. | 18 | 2002-08-01 | 2011-06-27 |
| Bioavailability Study of Metronidazole Capsules Under Fasting Conditions Metronidazole, Flagyl - To Determine the Bioequivalence Study Under Fasting | Phase 1 | Completed | Par Pharmaceutical, Inc. | 28 | 2002-08-01 | 2011-06-27 |
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Fasting (19) · Lecithin Cholesterol Acyltransferase Deficiency (11) · Anorexia (2) · Body Weight (2) · Cachexia (2) · Weight Loss (2) · Dermatitis, Atopic (1) · Kidney Failure, Chronic (1) · Lung Neoplasms (1) · Neoplasms (1) · Otitis Externa (1) · Pancreatic Neoplasms (1) · Renal Insufficiency (1)
Doxycycline (5) · Ondansetron (4) · Megestrol Acetate (3) · Buspirone (2) · Cabergoline (2) · Ciprofloxacin (2) · Clonazepam (2) · Dexamethasone (2) · Leflunomide (2) · Lisinopril (2) · Metronidazole (2) · Propranolol (2) · Torsemide (2) · Ultracet (2) · Acetaminophen (1)
Canada (14) · United States (10) · Puerto Rico (1)
Eric Masson, Pharm.D. (5) · Christian Aumais (3) · Clifford L Ferguson, MD (2) · Eric Masson (2) · Gary Shillito (2) · Lynn D Kramer, MD (2) · Ralph Scallion (2) · Ali Ziaee (1) · Antonio Pizzaro (1) · Bart Frizzell, MD (1) · Benoit Girard, M.D. (1) · Chandra S Vattikonda, Ph.D. (1) · Chandra Vattikonda, Ph.D. (1) · Christian Aumais, M.D (1) · Christian Sicard, M.D (1)