Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period, Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant Following a High-Fat Meal
The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by
TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study
consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules
manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive
dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.
The study will enroll approximately 120 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:
- Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)
- Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)
- Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)
- Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)
All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30
minutes following the beginning of a high-fat/high calorie breakfast of each treatment
period.
This single center trial will be conducted in the United States. The overall time to
participate in this study is approximately 86 days. Participants will be contacted by phone
call approximately 10 days after the last dose of study drug for a follow-up assessment.
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