NCT03131895

Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).

Detailed description

The drug being tested in this study is called dexlansoprazole. This study will compare bioavailability of dexlansoprazole from 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TOB relative to the corresponding 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TPC. The study will enroll approximately 104 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatment sequences: * Dexlansoprazole 30 mg TOB followed by Dexlansoprazole 30 mg TPC * Dexlansoprazole 30 mg TPC followed by Dexlansoprazole 30 mg TOB * Dexlansoprazole 60 mg TOB followed by Dexlansoprazole 60 mg TPC * Dexlansoprazole 60 mg TPC followed by Dexlansoprazole 60 mg TOB All participants will be asked to take single oral dose of dexlansoprazole at the same time on Day 1 of each Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 18 days. Participants will visit the clinic on Day -1 and remained confined until Day 2 of Period 1 and 2. A washout period of minimum 5 days will be maintained between the doses in each Period. Participants will be contacted by telephone 10 (+/-2) 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.
DRUG	30 mg dexlansoprazole capsules manufactured at TPC	Dexlansoprazole delayed-release.
DRUG	60 mg dexlansoprazole capsules manufactured at TOB	Dexlansoprazole delayed-release.
DRUG	60 mg dexlansoprazole capsules manufactured at TPC	Dexlansoprazole delayed-release.

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-07-03
• Completion: 2017-07-31
• First posted: 2017-04-27
• Last updated: 2019-06-14
• Results posted: 2019-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study