Healthy ParticipantsPhase 1NCT03083639

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

A Phase 1 study testing Esomeprazole Capsule and Esomeprazole Tablet in people with Healthy Participants, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Esomeprazole Capsule and Esomeprazole Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2017to 13 May 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, 66219

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Healthy Participants
Being tested: Esomeprazole Capsule, Esomeprazole Tablet
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esomeprazole CapsuleDrug
Also called Nexium
Esomeprazole Capsule
Esomeprazole TabletDrug
Also called Nexium
Esomeprazole Tablet

Study groups in NCT03083639
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Esomeprazole Capsule; Drug: Esomeprazole Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201713 May 2017

First posted20 Mar 2017
Study start27 Mar 2017
Primary completion13 May 2017
Study completion13 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03083639
Sponsor's protocol ID: Esomeprazole-1001
Other IDs: U1111-1189-8028, 03083639
Status last verified: Mar 2019
First submitted: 14 Mar 2017
Last updated: 14 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03083639
Acronym / sponsor ID: Esomeprazole-1001
Conditions: Healthy Participants
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 27 Mar 2017 (actual)
Primary completion: 13 May 2017 (actual)
Study completion: 13 May 2017 (actual)
First posted: 20 Mar 2017 (actual)
Results: Posted 14 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet	Experimental	Drug: Esomeprazole Capsule, Drug: Esomeprazole TabletEsomeprazole 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	Experimental	Drug: Esomeprazole Capsule, Drug: Esomeprazole TabletEsomeprazole 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Esomeprazole CapsuleAlso: NexiumEsomeprazole Capsule	Drug	Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet, Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule
Esomeprazole TabletAlso: NexiumEsomeprazole Tablet	Drug	Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet, Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule

Primary outcome

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
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
Cmax: Maximum Observed Plasma Concentration for Esomeprazole
Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose

Results and safety

Results posted to the registry on 14 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen A + Regimen B	26	26
Regimen B + Regimen A	26	26

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Regimen A n = 51	Regimen B n = 49
Value	1908.0 (66.0)	1922.2 (57.9)

Regimen A vs Regimen B: Point estimate: 1.018 (90% CI 0.969 to 1.070)

Population analysed: The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Regimen A n = 51	Regimen B n = 51
Value	1884.6 (64.3)	1882.6 (57.5)

Regimen A vs Regimen B: Point estimate: 0.993 (90% CI 0.939 to 1.050)

Population analysed: The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B.

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Esomeprazole

Time frame: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Regimen A n = 51	Regimen B n = 51
Value	933.29 (44.5)	872.38 (43.5)

Regimen A vs Regimen B: Point estimate: 0.942 (90% CI 0.880 to 1.009)

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A	0 of 51 (0%)	4 of 51 (7.8%)	0 of 51
Regimen B	0 of 51 (0%)	3 of 51 (5.9%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Esomeprazole Capsule and Esomeprazole Tablet in people with Healthy Participants, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.