Conditions: Bioavailability
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 52
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Two Dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2. arm 2: Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.

Interventions: intervention 1: Dexlansoprazole Delayed Release Orally Disintegrating Tablets intervention 2: Dexlansoprazole Delayed Release Capsules
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release, orally disintegrating (OD) tablets intervention 2: Dexlansoprazole delayed-release capsules

Protocol document: