Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
Detailed Description
The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-rel...
Eligibility Criteria
Inclusion
- Is a healthy adult man or woman of Chinese descent.
- Is aged 18 to 45 years, inclusive, at the time of informed consent and study medication dose.
- Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m\^2), inclusive at Screening Visit.
Exclusion
- Has a known hypersensitivity to any component of the formulation of dexlansoprazole or other drug with the same mechanism of action (including lansoprazole, omeprazole, esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and for 48 hours prior to each clinic visit and drugs throughout the study.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1) or is unwilling to abstain from these products for the duration of the study.
- Has poor peripheral venous access.
- Has donated blood products (such as plasma), whole blood or had a significant blood loss (450 millimeter \[mL\]) within 56 days of Day 1.
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03316976
Start Date
November 22 2017
End Date
February 8 2018
Last Update
May 10 2019
Active Locations (1)
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1
Phase I Clinical Trial Department
Beijing, Beijing Municipality, China, 100005