BioequivalencePhase 1NCT05235217

Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

A Phase 1 study testing Test product (T) 40 mg Hard Gelatin Capsules and Reference product (R) 40 mg Hard Gelatin Capsules in people with Bioequivalence, run by Future University in Egypt at 1 site in Egypt.

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 current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for: Bioequivalence
What is being tested?: Test product (T) 40 mg Hard Gelatin Capsules and Reference product (R) 40 mg Hard Gelatin Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteEgypt
Study dates: 3 Jun 2021to 18 Jun 2021
Phase: Phase 1
Are there results?: None posted in the registry

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 44 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent is obtained for study.
Age 18 - 55 years,
Body mass index between 18.5 and 30 kg/m2
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
Vital signs without significant deviations.
All laboratory screening results are within the normal range or clinically non-significant

Who cannot join

History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
Any confirmed significant allergic reactions against any drug, or multiple allergies.
Clinically significant illness 28 days before study period I.
Alcohol or any solvent intake.
Regular use of medication.

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Positive urine screening of drugs of abuse.
Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
Blood donation within the past 60 days.
Participation in another bioequivalence study within 60 days prior to the start of period I of the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Future Research Center (FRC)
Cairo

Other trials in Egypt

About this study

Official title: A Randomized, Single-Dose, Partial Replicate, Three-period, Three-sequence, Open-Label, Bioequivalence Study Comparing Esomeprazole in Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions

Read the detailed description

A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.

Conditions: Bioequivalence
Being tested: Test product (T) 40 mg Hard Gelatin Capsules, Reference product (R) 40 mg Hard Gelatin Capsules
Keywords: Esomeprazole, Bioequivalence, Randomized, Replicate

What participants receive

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

Test product (T) 40 mg Hard Gelatin CapsulesDrug
Hard Gelatin Capsules products containing 40 mg Esomeprazole
Reference product (R) 40 mg Hard Gelatin CapsulesDrug
Reference product (R) 40 mg Hard Gelatin Capsules

Study groups in NCT05235217
Study group	Role	What they receive
Test product (T) 40 mg Hard Gelatin Capsules	Experimental	Single oral dose of 40 mg capsule Receives: Drug: Test product (T) 40 mg Hard Gelatin Capsules
Reference product (R) 40 mg Hard Gelatin Capsules (first dose)	Active comparator	Single oral dose of 40 mg capsule Receives: Drug: Reference product (R) 40 mg Hard Gelatin Capsules
Reference product (R) 40 mg Hard Gelatin Capsules (second dose)	Active comparator	Single oral dose of 40 mg capsule Receives: Drug: Reference product (R) 40 mg Hard Gelatin Capsules

What is being measured

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

Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Esomeprazole peak concentration
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast)
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose

Secondary outcomes (3)

Maximum time (Tmax)
Time until Cmax is reached
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Elimination Rate Constant (Kel)
Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Plasma concentration half-life (t1/2)
t1/2 is the time taken for the plasma concentration of a drug to reduce to half its original value. It is used to estimate how long it takes for a drug to be removed from your body.
Measured: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 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.

3 Jun 202118 Jun 2021

First posted11 Feb 2022
Study start3 Jun 2021
Primary completion18 Jun 2021
Study completion18 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BioequivalenceStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study.
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05235217
Sponsor's protocol ID: RAZ-B-21-046
Status last verified: Jan 2022
First submitted: 31 Jan 2022
Last updated: 11 Feb 2022
Results posted: No
FDA-regulated drug: No
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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Dose, Partial Replicate, Three-period, Three-sequence, Open-Label, Bioequivalence Study Comparing Esomeprazole in Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT05235217
Acronym / sponsor ID: RAZ-B-21-046
Conditions: Bioequivalence
Keywords: Esomeprazole, Bioequivalence, Randomized, Replicate
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Future University in EgyptUniversity, hospital or other
Study start: 3 Jun 2021 (actual)
Primary completion: 18 Jun 2021 (actual)
Study completion: 18 Jun 2021 (actual)
First posted: 11 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study.

Arm	Type	Receives
Test product (T) 40 mg Hard Gelatin Capsules	Experimental	Drug: Test product (T) 40 mg Hard Gelatin CapsulesSingle oral dose of 40 mg capsule
Reference product (R) 40 mg Hard Gelatin Capsules (first dose)	Active comparator	Drug: Reference product (R) 40 mg Hard Gelatin CapsulesSingle oral dose of 40 mg capsule
Reference product (R) 40 mg Hard Gelatin Capsules (second dose)	Active comparator	Drug: Reference product (R) 40 mg Hard Gelatin CapsulesSingle oral dose of 40 mg capsule

Who may qualify

Ages: 18 to 44 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Written informed consent is obtained for study.
Age 18 - 55 years,
Body mass index between 18.5 and 30 kg/m2
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
Vital signs without significant deviations.

Key exclusion criteria (11 listed)

History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
Any confirmed significant allergic reactions against any drug, or multiple allergies.
Clinically significant illness 28 days before study period I.
Alcohol or any solvent intake.

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
Test product (T) 40 mg Hard Gelatin CapsulesHard Gelatin Capsules products containing 40 mg Esomeprazole	Drug	Test product (T) 40 mg Hard Gelatin Capsules
Reference product (R) 40 mg Hard Gelatin CapsulesReference product (R) 40 mg Hard Gelatin Capsules	Drug	Reference product (R) 40 mg Hard Gelatin Capsules (first dose), Reference product (R) 40 mg Hard Gelatin Capsules (second dose)

Primary outcome

Maximum plasma concentration (Cmax)
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Cmax is observed as the maximum of Esomeprazole peak concentration
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast)
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")

3 secondary outcomes

Maximum time (Tmax)
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Elimination Rate Constant (Kel)
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose
Plasma concentration half-life (t1/2)
Time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.

Related trials for Bioequivalence

Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
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Active, not recruitingPhase 1
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Prostatic Neoplasms
RecruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 6 inclusion and 11 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 11 Feb 2022. 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum plasma concentration (Cmax) (time frame: Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 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 NCT05235217.

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 11 Feb 2022.