Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, 66219, United States
NCT Number: NCT03083639
The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in healthy participants in order to evaluate the bioequivalence between a single oral dose of esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:
All participants will be asked to take one capsule or tablet on Day 1 of each Intervention Period based on the treatment sequence to which the participant has been assigned.
This single center trial will be conducted in the United States. The overall duration to participate in this study is 36 days. Participants will visit the clinic on Day -1 and remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6 days will be maintained between the dose in each Intervention Period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esomeprazole Capsule
Other names: Nexium
Esomeprazole Tablet
Other names: Nexium
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Takeda
Industry
A Phase 1, Randomized, Open-label, 2-way Cross-over Study to Evaluate the Bioequivalence Between a Single Oral Dose of Esomeprazole 40 mg Capsules and Esomeprazole 40 mg Tablets in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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