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A comparative pharmacokinetic study of diazepam nasal spray in in Chinese subjects

Trial Profile

A comparative pharmacokinetic study of diazepam nasal spray in in Chinese subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jul 2023

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At a glance

  • Drugs Diazepam (Primary) ; Diazepam
  • Indications Epilepsy
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 12 Jun 2023 According to a China Medical System media release, the company announced that on June 7 2023, the New Drug Application (NDA) of Diazepam Nasal Spray received approval from the National Medical Products Administration of China (NMPA).
    • 05 Jul 2021 According to a China Medical System media release, New Drug Application of Diazepam Nasal Spray (the "Product") has been accepted by the National Medical Products Administration of the People's Republic of China.
    • 21 Oct 2020 According to a China Medical System media release, the clinical trial notice issued by China NMPA, the company has to conduct this bridging trial to support its registration of the drug in China.

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