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Last Updated: November 2, 2024

CLINICAL TRIALS PROFILE FOR OXAZEPAM


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505(b)(2) Clinical Trials for OXAZEPAM

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 NCT03404817 ↗ Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations Completed National Institute on Drug Abuse (NIDA) Phase 1 2018-03-01 This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences
New Formulation NCT03404817 ↗ Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations Completed Embera NeuroTherapeutics, Inc. Phase 1 2018-03-01 This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for OXAZEPAM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000661 ↗ The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT) and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.
NCT00000897 ↗ A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00149110 ↗ Chronos: the Use of Chronobiological Treatment in Depression Completed Eli Lilly and Company N/A 2005-09-01 The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
NCT00149110 ↗ Chronos: the Use of Chronobiological Treatment in Depression Completed The County of Frederiksborg N/A 2005-09-01 The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OXAZEPAM

Condition Name

Condition Name for OXAZEPAM
Intervention Trials
Cocaine Use Disorder 4
Tobacco Use Disorder 3
HIV Infections 2
Severe Alcohol Use Disorder (DSM 5) 1
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Condition MeSH

Condition MeSH for OXAZEPAM
Intervention Trials
Disease 4
Tobacco Use Disorder 3
Alcoholism 2
HIV Infections 2
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Clinical Trial Locations for OXAZEPAM

Trials by Country

Trials by Country for OXAZEPAM
Location Trials
United States 18
Italy 2
Denmark 1
Germany 1
Austria 1
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Trials by US State

Trials by US State for OXAZEPAM
Location Trials
California 5
North Carolina 3
Louisiana 2
Florida 2
South Carolina 1
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Clinical Trial Progress for OXAZEPAM

Clinical Trial Phase

Clinical Trial Phase for OXAZEPAM
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for OXAZEPAM
Clinical Trial Phase Trials
Completed 10
Recruiting 3
Not yet recruiting 1
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Clinical Trial Sponsors for OXAZEPAM

Sponsor Name

Sponsor Name for OXAZEPAM
Sponsor Trials
Embera NeuroTherapeutics, Inc. 7
National Institute on Drug Abuse (NIDA) 5
National Institute of Allergy and Infectious Diseases (NIAID) 2
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Sponsor Type

Sponsor Type for OXAZEPAM
Sponsor Trials
Other 11
Industry 11
NIH 7
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