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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083639
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Esomeprazole Capsule Drug: Esomeprazole Tablet Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : May 13, 2017
Actual Study Completion Date : May 13, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Esomeprazole 40 mg Capsule + Esomeprazole 40 mg 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.
 Drug: Esomeprazole Capsule
Esomeprazole Capsule
Other Name: Nexium

Drug: Esomeprazole Tablet
Esomeprazole Tablet
Other Name: Nexium
Experimental: Esomeprazole 40 mg Tablet + Esomeprazole 40 mg 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.
 Drug: Esomeprazole Capsule
Esomeprazole Capsule
Other Name: Nexium

Drug: Esomeprazole Tablet
Esomeprazole Tablet
Other Name: Nexium


Outcome Measures
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Primary Outcome Measures :
  1. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose ]
  2. AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose ]
  3. Cmax: Maximum Observed Plasma Concentration for Esomeprazole [ Time Frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083639


Locations
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United States, Kansas
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Statistical Analysis Plan  [PDF] June 1, 2017
Study Protocol  [PDF] March 7, 2017

More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03083639    
Other Study ID Numbers: Esomeprazole-1001
U1111-1189-8028 ( Other Identifier: WHO )
03083639 ( Registry Identifier: ClinicalTrials.gov )
First Posted: March 20, 2017    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action