A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Esomeprazole Capsule; Drug: Esomeprazole Tablet

• Registration Number: NCT03083639
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.

Detailed Description

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:

* Esomeprazole 40 mg capsule + Esomeprazole 40 mg tablet

* Esomeprazole 40 mg tablet + Esomeprazole 40 mg capsule

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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Study Start: 2017-03-27
• Primary Completion: 2017-05-13
• Study Completion: 2017-05-13
• Results First Submitted: 2018-05-08
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-15
• Last Update Submitted: 2019-03-15
• Results First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Is a healthy adult male or female participant.
2. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.

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Exclusion Criteria

1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted.
2. Has a history of significant gastro intestinal (GI) disorders manifested with persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis), or any gastrointestinal-related surgical intervention..
3. Has a known hypersensitivity to any component of the formulation of esomeprazole capsules or tablets or compounds with the same mechanism of action (dexlansoprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet	Esomeprazole Tablet	Esomeprazole 40 mg, capsule, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg tablet, orally, once on Day 1 of Intervention Period 2.
Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet	Esomeprazole Capsule	Esomeprazole 40 mg, capsule, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg tablet, orally, once on Day 1 of Intervention Period 2.
Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule	Esomeprazole Capsule	Esomeprazole 40 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg capsule, orally, once on Day 1 of Intervention Period 2.
Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule	Esomeprazole Tablet	Esomeprazole 40 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg capsule, orally, once on Day 1 of Intervention Period 2.

Primary Outcome Measures

Name	Time	Method
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole	Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Esomeprazole	Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole	Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.; 🇺🇸 Lenexa, Kansas, United States