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NCT03083639 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Participants, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target
1
Study location

NCT03083639 is a Phase 1 study of Healthy Participants that has completed, run by Takeda. The registered enrollment target is 52 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03083639, a Phase 1 study of Healthy Participants, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target
1
Study location

Study Summary

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

Conditions Studied

Interventions

  • DRUG Esomeprazole Capsule
  • DRUG Esomeprazole Tablet

Study Locations (1)

Kansas

  • Pharmaceutical Research Associates, Inc. - Lenexa

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2017-03-27
Est. Completion 2017-05-13
Phase Phase 1

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT03083639

The ClinicalTrials.gov registry entry for NCT03083639 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (20% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 2 interventions - of which Esomeprazole Capsule is the first listed.

NCT03083639 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT03083639 about?

NCT03083639 is a clinical study titled "A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants". The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.

What is the current status of trial NCT03083639?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-03-27. Estimated completion is 2017-05-13.

What conditions does trial NCT03083639 study?

This clinical trial studies the following conditions: Healthy Participants.

What interventions are being tested in trial NCT03083639?

The interventions under investigation include: Esomeprazole Capsule (DRUG), Esomeprazole Tablet (DRUG).

Who is sponsoring clinical trial NCT03083639?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03083639 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.