This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet formulations containing Clotiazepam 5 mg.
The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 Tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

Start Date11 Mar 2020

Sponsor / Collaborator

Laboratorios Andrómaco SA

100 Clinical Results associated with Clotiazepam

100 Translational Medicine associated with Clotiazepam

100 Patents (Medical) associated with Clotiazepam

307

Literatures (Medical) associated with Clotiazepam

01 Apr 2024·Analytical and Bioanalytical Chemistry

Development of a rapid-fire drug screening method by probe electrospray ionization tandem mass spectrometry for human urine (RaDPi-U)

Article

Author: Murata, Tasuku ; Zaitsu, Kei ; Hisatsune, Kazuaki ; Asano, Tomomi ; Iguchi, Akira ; Ogata, Koretsugu ; Taniguchi, Masaru

Drug screening tests are mandatory in the search for drugs in forensic biological samples, and immunological methods and mass spectrometry (e.g., gas chromatography-mass spectrometry and liquid chromatography-tandem mass spectrometry) are commonly used for that purpose. However, these methods have some drawbacks, and developing new screening methods is required. In this study, we develop a rapid-fire drug screening method by probe electrospray ionization tandem mass spectrometry (PESI-MS/MS), which is an ambient ionization mass spectrometry method, for human urine, named RaDPi-U. RaDPi-U is carried out in three steps: (1) mixing urine with internal standard (IS) solution and ethanol, followed by vortexing; (2) pipetting the mixture onto a sample plate for PESI; and (3) rapid-fire analysis by PESI-MS/MS. RaDPi-U targets 40 forensically important drugs, which include illegal drugs, hypnotics, and psychoactive substances. The analytical results were obtained within 3 min because of the above-mentioned simple workflow of RaDPi-U. The calibration curves of each analyte were constructed using the IS method, and they were quantitatively valid, resulting in good linearity (0.972-0.999) with a satisfactory lower limit of detection and lower limit of quantitation (0.01-7.1 ng/mL and 0.02-21 ng/mL, respectively). Further, both trueness and precisions were 28% or less, demonstrating the high reliability and repeatability of the method. Finally, we applied RaDPi-U to three postmortem urine specimens and successfully detected different drugs in each urine sample. The practicality of the method is proven, and RaDPi-U will be a strong tool as a rapid-fire drug screening method not only in forensic toxicology but also in clinical toxicology.

01 Sep 2023·Psychiatry and Clinical Neurosciences Reports

Clinical practice for unspecified anxiety disorder in primary care

Article

Author: Watanabe, Koichiro ; Aoki, Yumi ; Takeshima, Masahiro ; Inada, Ken ; Yoshida, Eriko ; Hori, Hikaru ; Sakurai, Hitoshi ; Kise, Morito ; Shimizu, Eiji ; Ie, Kenya ; Takaesu, Yoshikazu ; Inada, Yasushi ; Yamada, Hisashi ; Mishima, Kazuo ; Tsuboi, Takashi

AbstractAimClinicians face difficulties in making treatment decisions for unspecified anxiety disorder due to the absence of any treatment guidelines. The objective of this study was to investigate how familiar and how often primary care physicians use pharmacological and nonpharmacological approaches to manage the disorder.MethodsA survey was conducted among 117 primary care physicians in Japan who were asked to assess the familiarity of using each treatment option for unspecified anxiety disorder on a binary response scale (0 = “unfamiliar,” 1 = “familiar”) and the frequency on a nine‐point Likert scale (1 = “never used,” 9 = “frequently used”).ResultsWhile several benzodiazepine anxiolytics were familiar to primary care physicians, the frequencies of prescribing them, including alprazolam (4.6 ± 2.6), ethyl loflazepate (3.6 ± 2.4), and clotiazepam (3.5 ± 2.3), were low. In contrast, certain nonpharmacological options, including lifestyle changes (5.4 ± 2.3), coping strategies (5.1 ± 2.7), and psychoeducation for anxiety (5.1 ± 2.7), were more commonly utilized, but to a modest extent. When a benzodiazepine anxiolytic drug failed to be effective, primary care physicians selected the following management strategies to a relatively high degree: differential diagnosis (6.4 ± 2.4), referral to a specialist hospital (5.9 ± 2.5), lifestyle changes (5.2 ± 2.5), and switching to selective serotonin reuptake inhibitor (5.1 ± 2.4).ConclusionPrimary care physicians exercise caution when prescribing benzodiazepine anxiolytics for unspecified anxiety disorder. Nonpharmacological interventions and switching to SSRI are modestly employed as primary treatment options and alternatives to benzodiazepine anxiolytics. To ensure the safe and effective treatment of unspecified anxiety disorder in primary care, more information should be provided from field experts.

01 Jul 2023·Contact dermatitis

Localized delayed-type hypersensitivity of face and lips from alprazolam and cross-reactivity with other benzodiazepines.

Author: De Pasquale, Tiziana Maria Angela ; Buonomo, Alessandro ; Pucci, Stefano

Allergic reactions to benzodiazepines are relatively rare.Besides airborne (occupational) allergic contact dermatitis, which has been frequently reported about, both immediate and delayed-type hypersensitivities have been described, the latter including, among others, fixed drug eruption, generalized reactions, and Stevens-Johnson′s syndrome.A 40-yr-old man was admitted to the allergy unit of the Civitanova Marche hospital with a history of two episodes of an itchy eczematous rash of the face and 1 episode of lip edema, both occurring after the oral intake of alprazolam.The patient had started treatment with alprazolam about 10 mo before the reactions started to occur.Patch tests with the oral liquid formulations of alprazolam (0.75 mg/mL), diazepam (5 mg/mL) delorazepam (1 mg/mL), lormetazepam (2.5 mg/mL), bromazepam (2.5 mg/mL), triazolam (0.375 mg/mL), clotiazepam (10 mg/mL) and lorazepam (2 mg/mL) were performed.Even if the clin. picture was not typical, clin. history and patch test results were suggestive of a delayed-type hypersensitivity to alprazolam, with eventually cross-reactivity to diazepam, delorazepam, lormetazepam ad bromazepam.In our case, patch tests showed a good neg. predictive value since the patients tolerated lorazepam, clotiazepam and midazolam which were patch-test neg.Delayed-type allergy to benzodiazepines should be taken in consideration when the clin. history is highly suggestive, even when the clin. picture is atypical.

100 Deals associated with Clotiazepam

External Link

KEGG	Wiki	ATC	Drug Bank
D01328	Clotiazepam	N05BA21	DB01559

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anxiety Disorders	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jan 1998
Catatonia	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jan 1998
Sleep Initiation and Maintenance Disorders	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jan 1998
Dysautonomia Like Disorder	Japan	Mitsubishi Tanabe Pharma Corp.	31 May 1988

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