CLINICAL TRIALS PROFILE FOR SONATA
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505(b)(2) Clinical Trials for Sonata
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT00878553 ↗ | Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 | Completed | INC Research Limited | Phase 2 | 2010-05-01 | SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings. |
| New Formulation | NCT00878553 ↗ | Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 | Completed | Somnus Therapeutics, Inc. | Phase 2 | 2010-05-01 | SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Sonata
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00530101 ↗ | The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity | Completed | Mallinckrodt | Phase 1 | 2004-07-01 | The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans. This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine. |
| NCT00530101 ↗ | The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity | Completed | University of Miami | Phase 1 | 2004-07-01 | The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans. This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine. |
| NCT00694187 ↗ | Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions | Completed | Roxane Laboratories | N/A | 2004-01-01 | The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design |
| NCT00694317 ↗ | Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions | Completed | Roxane Laboratories | N/A | 2004-02-01 | The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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