NCT02064907

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants

A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue Relative to Oral Administration of One 60 mg Dexlansoprazole Delayed-Release Capsule in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.

Detailed description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole. The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods: * Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days * One dexlansoprazole 60 mg capsule for 5 days. All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study. This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment. The overall time to participate in this study is up to 57 days.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	Dexlansoprazole Delayed Release Orally Disintegrating Tablets	Dexlansoprazole delayed-release, orally disintegrating (OD) tablets
DRUG	Dexlansoprazole Delayed Release Capsules	Dexlansoprazole delayed-release capsules

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2014-02-17
• Last updated: 2015-04-14
• Results posted: 2015-04-14

Locations

1 site across 1 country: United States