NCT03801148

A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.).

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	30 mg dexlansoprazole capsules manufactured at TOB	Dexlansoprazole delayed-release capsules.
DRUG	30 mg dexlansoprazole capsules manufactured at TPC	Dexlansoprazole delayed-release capsules.
DRUG	60 mg dexlansoprazole capsules manufactured at TOB	Dexlansoprazole delayed-release capsules.
DRUG	60 mg dexlansoprazole capsules manufactured at TPC	Dexlansoprazole delayed-release capsules.

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-02-25
• Completion: 2019-04-09
• First posted: 2019-01-11
• Last updated: 2020-03-19
• Results posted: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study