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A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects

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Trial Profile

A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Dec 2021

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At a glance

  • Drugs Vonoprazan (Primary)
  • Indications Duodenal ulcer; Erosive oesophagitis; Gastric ulcer; Gastro-oesophageal reflux; Helicobacter infections; Peptic ulcer; Reflux oesophagitis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Takeda

Most Recent Events

  • 22 Mar 2021 According to an Otsuka Pharmaceutical media release, Takeda has applied for approval to manufacture and market TAKECAB OD 10 mg and TAKECAB OD 20 mg as additional formulations of TAKECAB 10 mg and TAKECAB 20 mg, developed by Takeda for treating acid-related disease. The application for approval is based on this study and dissolution tests.
  • 28 Aug 2019 Status changed from recruiting to completed.
  • 22 Feb 2019 Status changed from not yet recruiting to recruiting.

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