Finding studies
Finding studies
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Lead
Takeda
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
