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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR SONATA

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505(b)(2) Clinical Trials for Sonata

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >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
NCT00829868 Zaleplon 10 mg Capsules Under Non-Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2004-02-01 The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.
NCT00829998 Zaleplon 10mg Capsules Under Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2004-02-01 The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sonata

Condition Name

Condition Name for Sonata
Intervention Trials
Short Term Treatment of Insomnia 2
Healthy 2
Dry Eye 1
Sleep Disorder 1
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Condition MeSH

Condition MeSH for Sonata
Intervention Trials
Cardiotoxicity 1
Diabetic Nephropathies 1
Keratoconjunctivitis Sicca 1
Dry Eye Syndromes 1
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Clinical Trial Locations for Sonata

Trials by Country

Trials by Country for Sonata
Location Trials
United States 20
Korea, Republic of 1
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Trials by US State

Trials by US State for Sonata
Location Trials
Texas 5
Florida 2
Tennessee 1
South Carolina 1
Pennsylvania 1
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Clinical Trial Progress for Sonata

Clinical Trial Phase

Clinical Trial Phase for Sonata
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Sonata
Clinical Trial Phase Trials
Completed 8
Unknown status 1
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Clinical Trial Sponsors for Sonata

Sponsor Name

Sponsor Name for Sonata
Sponsor Trials
Teva Pharmaceuticals USA 2
Roxane Laboratories 2
Mallinckrodt 1
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Sponsor Type

Sponsor Type for Sonata
Sponsor Trials
Industry 9
U.S. Fed 1
Other 1
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