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

NCT03083639 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: Esomeprazole-1001U1111-1189-802803083639
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (2)

Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet

EXPERIMENTAL

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; Drug: Esomeprazole Tablet

Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule

EXPERIMENTAL

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; Drug: Esomeprazole Tablet

Interventions

Esomeprazole Capsule DRUG

Esomeprazole Capsule

Also known as: Nexium

Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet; Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule

Esomeprazole Tablet DRUG

Esomeprazole Tablet

Also known as: Nexium

Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet; Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy adult male or female participant.
• Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• 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.

You may not qualify if:

• 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.
• 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..
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 27, 2017
• Primary Completion: May 13, 2017
• Study Completion: May 13, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Locations

US (1)