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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083639
• Other study ID #: Esomeprazole-1001
• Secondary ID: U1111-1189-80280
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2017
• Est. completion date: May 13, 2017

Study information

• Verified date: March 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 13, 2017
• Est. primary completion date: May 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Esomeprazole Capsule
Esomeprazole Capsule
• Esomeprazole Tablet
Esomeprazole Tablet

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC8: 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
Primary	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
Primary	Cmax: Maximum Observed Plasma Concentration for Esomeprazole		Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose