Healthy VolunteersPhase 1NCT03131895

Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants

A Phase 1 study testing 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC and 60 mg dexlansoprazole capsules manufactured at TOB in people with Healthy Volunteers, 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 assess the bioavailability of dexlansoprazole from a 30 milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule manufactured at Takeda Pharmaceutical Company Ltd. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC and 60 mg dexlansoprazole capsules manufactured at TOB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 25 Apr 2017to 31 Jul 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

Healthy men and women aged 18 to 55 years old, inclusive, with a body mass index between 18 and 30 kilogram per square meter (kg/m^2), inclusive.
Who are capable of understanding and complying with protocol requirements.
Must be in good health as determined by a physician based upon medical history, vital signs, electrocardiogram (ECG), and physical examination.
Must have clinical chemistry, hematology, and complete urinalysis (after fasting for at least 8 hours) at Screening and Check-in (Day -1 of Period 1) results within the reference range for the testing laboratory unless the out-of-range results are deemed not clinically significant by the investigator.
Must sign a written informed consent form (ICF) prior to initiation of study procedures.

Who cannot join

Has a history of significant gastrointestinal (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 (EE) with frequent [more than once per week] occurrence of heartburn).
Has consumed medications, certain foods, and supplements, including prescription and over-the-counter medications, within the protocol-specified time periods prior to Check-in (Day -1 of Period 1), or is unwilling to agree to abstain from these products.
Have received dexlansoprazole in a previous clinical study or as a therapeutic agent within 6 months of Screening,
Have a known hypersensitivity to any component of the formulation of dexlansoprazole capsules or other drugs with the same mechanism of action (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole), or related compounds.
Any significant results from physical examination or clinical laboratory results that make the participant unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRAHS Phase 1 unit
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant

Read the detailed description

The drug being tested in this study is called dexlansoprazole. This study will compare bioavailability of dexlansoprazole from 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TOB relative to the corresponding 30 mg and 60 mg dexlansoprazole delayed release capsules manufactured at TPC. The study will enroll approximately 104 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatment sequences:

Dexlansoprazole 30 mg TOB followed by Dexlansoprazole 30 mg TPC
Dexlansoprazole 30 mg TPC followed by Dexlansoprazole 30 mg TOB
Dexlansoprazole 60 mg TOB followed by Dexlansoprazole 60 mg TPC
Dexlansoprazole 60 mg TPC followed by Dexlansoprazole 60 mg TOB

All participants will be asked to take single oral dose of dexlansoprazole at the same time on Day 1 of each Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 18 days. Participants will visit the clinic on Day -1 and remained confined until Day 2 of Period 1 and 2. A washout period of minimum 5 days will be maintained between the doses in each Period. Participants will be contacted by telephone 10 (+/-2) days after the last dose of study drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB, 60 mg dexlansoprazole capsules manufactured at TPC
Keywords: Drug therapy

What participants receive

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

30 mg dexlansoprazole capsules manufactured at TOBDrug
Dexlansoprazole delayed-release.
30 mg dexlansoprazole capsules manufactured at TPCDrug
Dexlansoprazole delayed-release.
60 mg dexlansoprazole capsules manufactured at TOBDrug
Dexlansoprazole delayed-release.
60 mg dexlansoprazole capsules manufactured at TPCDrug
Dexlansoprazole delayed-release.

Study groups in NCT03131895
Study group	Role	What they receive
Part 1, Sequence 1 (Regimen A, B)	Experimental	Dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once on Day 1 of Period 2 following a 10-hour fast. Receives: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC
Part 1, Sequence 2 (Regimen B, A)	Experimental	Dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once on Day 1 of Period 2 following a 10-hour fast. Receives: Drug: 30 mg dexlansoprazole capsules manufactured at TOB; Drug: 30 mg dexlansoprazole capsules manufactured at TPC
Part 2, Sequence 3 (Regimen C, D)	Experimental	Dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once on Day 1 of Period 2 following a 10-hour fast. Receives: Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC
Part 2, Sequence 4 (Regimen D, C)	Experimental	Dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regiment C [test]), orally, once on Day 1 of Period 2 following a 10-hour fast. Receives: Drug: 60 mg dexlansoprazole capsules manufactured at TOB; Drug: 60 mg dexlansoprazole capsules manufactured at TPC

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Measured: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
Measured: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
Measured: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose

Timeline

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

25 Apr 201731 Jul 2017

First posted27 Apr 2017
Study start25 Apr 2017
Primary completion3 Jul 2017
Study completion31 Jul 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 VolunteersStudies 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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03131895
Sponsor's protocol ID: TAK-390MR-1001
Other IDs: U1111-1184-2186
Status last verified: Mar 2019
First submitted: 24 Apr 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?

See locations

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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, Single-Center, Single-Dose, Two-Period Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda GmbH Plant Oranienburg Relative to Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda Pharmaceutical Company Limited Osaka Plant
ClinicalTrials.gov ID: NCT03131895
Acronym / sponsor ID: TAK-390MR-1001
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 25 Apr 2017 (actual)
Primary completion: 3 Jul 2017 (actual)
Study completion: 31 Jul 2017 (actual)
First posted: 27 Apr 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.

Detailed description

Dexlansoprazole 30 mg TOB followed by Dexlansoprazole 30 mg TPC
Dexlansoprazole 30 mg TPC followed by Dexlansoprazole 30 mg TOB
Dexlansoprazole 60 mg TOB followed by Dexlansoprazole 60 mg TPC
Dexlansoprazole 60 mg TPC followed by Dexlansoprazole 60 mg TOB

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part 1, Sequence 1 (Regimen A, B)	Experimental	Drug: 30 mg dexlansoprazole capsules manufactured at TOB, Drug: 30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once on Day 1 of Period 2 following a 10-hour fast.
Part 1, Sequence 2 (Regimen B, A)	Experimental	Drug: 30 mg dexlansoprazole capsules manufactured at TOB, Drug: 30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 30 mg, delayed-release capsule manufactured by TPC (Regimen B [reference]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 30 mg, delayed-release capsule manufactured by TOB (Regimen A [test]), orally, once on Day 1 of Period 2 following a 10-hour fast.
Part 2, Sequence 3 (Regimen C, D)	Experimental	Drug: 60 mg dexlansoprazole capsules manufactured at TOB, Drug: 60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regimen C [test]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once on Day 1 of Period 2 following a 10-hour fast.
Part 2, Sequence 4 (Regimen D, C)	Experimental	Drug: 60 mg dexlansoprazole capsules manufactured at TOB, Drug: 60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole 60 mg, delayed-release capsule manufactured by TPC (Regimen D [reference]), orally, once on Day 1 of Period 1 following a 10 hour fast, followed by minimum of 5 day washout period, followed by dexlansoprazole 60 mg, delayed-release capsule manufactured by TOB (Regiment C [test]), orally, once on Day 1 of Period 2 following a 10-hour fast.

Who may qualify

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

Key inclusion criteria (5 listed)

Healthy men and women aged 18 to 55 years old, inclusive, with a body mass index between 18 and 30 kilogram per square meter (kg/m^2), inclusive.
Who are capable of understanding and complying with protocol requirements.
Must be in good health as determined by a physician based upon medical history, vital signs, electrocardiogram (ECG), and physical examination.
Must have clinical chemistry, hematology, and complete urinalysis (after fasting for at least 8 hours) at Screening and Check-in (Day -1 of Period 1) results within the reference range for the testing laboratory unless the out-of-range results are deemed not clinically significant by the investigator.
Must sign a written informed consent form (ICF) prior to initiation of study procedures.

Key exclusion criteria (5 listed)

Has a history of significant gastrointestinal (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 (EE) with frequent [more than once per week] occurrence of heartburn).
Has consumed medications, certain foods, and supplements, including prescription and over-the-counter medications, within the protocol-specified time periods prior to Check-in (Day -1 of Period 1), or is unwilling to agree to abstain from these products.
Have received dexlansoprazole in a previous clinical study or as a therapeutic agent within 6 months of Screening,
Have a known hypersensitivity to any component of the formulation of dexlansoprazole capsules or other drugs with the same mechanism of action (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole), or related compounds.
Any significant results from physical examination or clinical laboratory results that make the participant unsuitable for the study.

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
30 mg dexlansoprazole capsules manufactured at TOBDexlansoprazole delayed-release.	Drug	Part 1, Sequence 1 (Regimen A, B), Part 1, Sequence 2 (Regimen B, A)
30 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole delayed-release.	Drug	Part 1, Sequence 1 (Regimen A, B), Part 1, Sequence 2 (Regimen B, A)
60 mg dexlansoprazole capsules manufactured at TOBDexlansoprazole delayed-release.	Drug	Part 2, Sequence 3 (Regimen C, D), Part 2, Sequence 4 (Regimen D, C)
60 mg dexlansoprazole capsules manufactured at TPCDexlansoprazole delayed-release.	Drug	Part 2, Sequence 3 (Regimen C, D), Part 2, Sequence 4 (Regimen D, C)

Primary outcome

Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Time frame: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
Time frame: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
Time frame: Day 1: pre-dose and at multiple time points (up to 24 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
Part 1: Dexlansoprazole 30 mg TOB+ Dexlansoprazole 30 mg TPC	28	28
Part 1: Dexlansoprazole 30 mg TPC + Dexlansoprazole 30 mg TOB	28	28
Part 2: Dexlansoprazole 60 mg TOB+ Dexlansoprazole 60 mg TPC	30	30
Part 2: Dexlansoprazole 60 mg TPC+ Dexlansoprazole 60 mg TOB	30	30

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

Time frame: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: nanogram/milliliter (ng/mL)

Measure	Dexlansoprazole 30 mg TOB n = 51	Dexlansoprazole 30 mg TPC n = 55	Dexlansoprazole 60 mg TOB n = 55	Dexlansoprazole 60 mg TPC n = 56
Value	515.7 (257.60)	519.5 (305.66)	1027.0 (598.74)	978.6 (581.34)

Dexlansoprazole 30 mg TOB vs Dexlansoprazole 30 mg TPC: Least square (LS) mean ratio: 1.0436 (90% CI 0.9453 to 1.1521), p = 0.5535, ANOVA
Dexlansoprazole 60 mg TOB vs Dexlansoprazole 60 mg TPC: LS mean ratio: 1.0185 (90% CI 0.9334 to 1.1113), p = 0.8920, ANOVA

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.

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole

Time frame: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: nanogram*hour per milliliter(ng*hour/mL)

Measure	Dexlansoprazole 30 mg TOB n = 51	Dexlansoprazole 30 mg TPC n = 55	Dexlansoprazole 60 mg TOB n = 55	Dexlansoprazole 60 mg TPC n = 56
Value	2416.3 (2280.91)	2327.6 (2052.94)	5715.5 (4521.84)	5684.7 (5361.88)

Dexlansoprazole 30 mg TOB vs Dexlansoprazole 30 mg TPC: LS mean ratio: 1.0390 (90% CI 0.9792 to 1.1024), p = 0.3209, ANOVA
Dexlansoprazole 60 mg TOB vs Dexlansoprazole 60 mg TPC: LS mean ratio: 1.0353 (90% CI 0.9719 to 1.1029), p = 0.3896, ANOVA

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.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole

Time frame: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: ng*hour/mL

Measure	Dexlansoprazole 30 mg TOB n = 51	Dexlansoprazole 30 mg TPC n = 55	Dexlansoprazole 60 mg TOB n = 55	Dexlansoprazole 60 mg TPC n = 56
Value	2579.6 (2760.38)	2420.6 (2322.58)	5746.2 (4785.72)	5630.4 (5527.34)

Dexlansoprazole 30 mg TOB vs Dexlansoprazole 30 mg TPC: LS mean ratio: 1.0335 (90% CI 0.9733 to 1.0975), p = 0.4163, ANOVA
Dexlansoprazole 60 mg TOB vs Dexlansoprazole 60 mg TPC: LS mean ratio: 1.0031 (90% CI 0.9458 to 1.0638), p = 0.9778, ANOVA

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. PK analysis set where data at specified time points was available.

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 (Day 37). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexlansoprazole 30 mg TOB	0 of 51 (0%)	8 of 51 (15.7%)	0 of 51
Dexlansoprazole 30 mg TPC	0 of 55 (0%)	9 of 55 (16.4%)	0 of 55
Dexlansoprazole 60 mg TOB	0 of 55 (0%)	8 of 55 (14.5%)	0 of 55
Dexlansoprazole 60 mg TPC	0 of 56 (0%)	11 of 56 (19.6%)	0 of 56

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?

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 5 inclusion and 5 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?

Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole (time frame: Day 1: pre-dose and at multiple time points (up to 24 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 NCT03131895.

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.