HealthyPhase 1NCT00889850
Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration
A Phase 1 study testing 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and INexium 40 mg MUPS tablets (AstraZeneca, France) in people with Healthy, run by Mepha Ltd. at 1 site in Germany.
Trial summary
The present study will be conducted in order to compare the bioavailability of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca, France) under single dose fasted and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and INexium 40 mg MUPS tablets (AstraZeneca, France)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Jun 2009
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has to:
- be Caucasian male
- be aged between 18-55 years, inclusive
- have a body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- be considered to be healthy on the basis of extensive pre-study eligibility assessment
- be a non-smoker or an ex-smoker for at least 1 month
- be willing and capable to confirm written consent to enrolment after ample information has been provided
Who cannot join
- Subjects cannot be included if they match any of the following exclusion criteria:
- existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
- presence of active gastric/duodenal ulcer or gastrointestinal bleeding, of enteritis like Crohn's disease or ulcerative colitis, clinically confirmed coronary heart disease and/or cerebrovascular disease, cardiac insufficiency (NYHA II-IV), severe liver insufficiency, or severe renal insufficiency
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- pathological ECG (12 standard leads)
- known allergic reactions to the active ingredient used, substituted benzimidazole or to other constituents of the pharmaceutical preparations
Show all 21Show fewer
- subjects with severe allergies or multiple drug allergies
- positive results of the urine drug screen
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
- positive anti-HIV-test, HBs-AG-test or anti-HCV-test
- lactose or fructose intolerance
- glucose-galactose malabsorption
- history of or current drug or alcohol dependence
- regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day
- subjects who are on a diet which could affect the pharmacokinetics of the drug
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- blood donation or other blood loss of more than 400 ml within the last two months prior to the start of the study
- participation in a clinical trial during the last two months prior to the start of the study
- subjects, who report a frequent occurrence of migraine attacks
- regular treatment with any systemically available medication (except hormonal replacement therapy e.g. L-thyroxine) within 14 days prior to the first administration of the study medication
- subjects suspected or known not to follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Randomised, Single-Dose, 2x2-Way Cross-Over Comparative Oral Bioavailability Study in Healthy Adult Male Subjects Under Fasted Conditions (Block I) and Under Fed Conditions (Block II); Comparison of 40 mg Esomeprazole Mepha Capsules (Test) With 40 mg Esomeprazole INexium MUPS Tablets (Reference)
The present study will be conducted in order to compare the bioavailability of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca, France) under single dose fasted and fed conditions.
The study will be conducted as a combined single dose study under fasted and fed conditions in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days between administrations.
Read the detailed description
- The primary objective of the single dose fasted part of the study is to compare the rate and extent of absorption of esomeprazole from 40 mg Esomeprazole Mepha capsules (Test) with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted conditions, determined by use of AUC0-tlast and Cmax obtained from esomeprazole plasma concentrations.
- The primary objective of the single dose fed in combination with the fasted part of the study is to compare the maximum concentration of esomeprazole determined after 40 mg Esomeprazole Mepha capsules (Test) single dose administration under fed conditions in comparison with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted and fed conditions.
- Conditions
- Healthy
- Being tested
- 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland), INexium 40 mg MUPS tablets (AstraZeneca, France)
- Keywords
- Healthy, Bioavailability, Bioequivalence, Esomeprazole, Bioavailability, Therapeutical Indication Not Studied
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)Drug
Also called Test
40 mg esomeprazole, single dose administration under fasted and fed condition
INexium 40 mg MUPS tablets (AstraZeneca, France)Drug
Also called Reference
40 mg esomeprazole, oral single dose administration under fasted and fed condition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral fasted administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) Receives: Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) |
| 2 | Active comparator | Oral fasted administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France) Receives: Drug: INexium 40 mg MUPS tablets (AstraZeneca, France) |
| 3 | Active comparator | Oral fed administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) Receives: Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) |
| 4 | Active comparator | Oral fed administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France) Receives: Drug: INexium 40 mg MUPS tablets (AstraZeneca, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pharmacokinetic parameters of esomeprazole after single oral doses of Esomeprazole Mepha capsules (Test) and 40 mg Esomeprazole INexium MUPS tablets (Reference) under fasted and fed conditions.
Measured: April - June 2009
Secondary outcomes (1)
Descriptive characterisation of safety and tolerability of the investigational products in the study population.
Measured: April - June 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mepha Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH
- Investigators
- Frank Donath, MD, Principal investigator, SocraTec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889850
- Sponsor's protocol ID
- ESO 001.2009
- Other IDs
- SocraTec: 1216es09ct, EudraCT: 2009-010941-29
- Status last verified
- Jun 2009
- First submitted
- 28 Apr 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomised, Single-Dose, 2x2-Way Cross-Over Comparative Oral Bioavailability Study in Healthy Adult Male Subjects Under Fasted Conditions (Block I) and Under Fed Conditions (Block II); Comparison of 40 mg Esomeprazole Mepha Capsules (Test) With 40 mg Esomeprazole INexium MUPS Tablets (Reference)
- ClinicalTrials.gov ID
- NCT00889850
- Acronym / sponsor ID
- ESO 001.2009
- Conditions
- Healthy
- Keywords
- Healthy, Bioavailability, Bioequivalence, Esomeprazole, Bioavailability, Therapeutical Indication Not Studied
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mepha Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- 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.
The present study will be conducted in order to compare the bioavailability of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca, France) under single dose fasted and fed conditions.
The study will be conducted as a combined single dose study under fasted and fed conditions in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days between administrations.
Detailed description
- The primary objective of the single dose fasted part of the study is to compare the rate and extent of absorption of esomeprazole from 40 mg Esomeprazole Mepha capsules (Test) with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted conditions, determined by use of AUC0-tlast and Cmax obtained from esomeprazole plasma concentrations.
- The primary objective of the single dose fed in combination with the fasted part of the study is to compare the maximum concentration of esomeprazole determined after 40 mg Esomeprazole Mepha capsules (Test) single dose administration under fed conditions in comparison with 40 mg Esomeprazole INexium MUPS tablets (Reference) after single dose administration under fasted and fed conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)Oral fasted administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) |
| 2 | Active comparator | Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)Oral fasted administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France) |
| 3 | Active comparator | Drug: 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)Oral fed administration of one capsule of 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) |
| 4 | Active comparator | Drug: INexium 40 mg MUPS tablets (AstraZeneca, France)Oral fed administration of one tablet of INexium 40 mg MUPS tablets (AstraZeneca, France) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject has to:
Key exclusion criteria (21 listed)
- Subjects cannot be included if they match any of the following exclusion criteria:
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 |
|---|---|---|
| 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)Also: Test40 mg esomeprazole, single dose administration under fasted and fed condition | Drug | 1, 3 |
| INexium 40 mg MUPS tablets (AstraZeneca, France)Also: Reference40 mg esomeprazole, oral single dose administration under fasted and fed condition | Drug | 2, 4 |
Primary outcome
Comparison of pharmacokinetic parameters of esomeprazole after single oral doses of Esomeprazole Mepha capsules (Test) and 40 mg Esomeprazole INexium MUPS tablets (Reference) under fasted and fed conditions.
Time frame: April - June 2009
1 secondary outcome
Descriptive characterisation of safety and tolerability of the investigational products in the study population.
Time frame: April - June 2009
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 23 Jun 2009.
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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.
Frank Donath, MD principal investigator
SocraTec R&D GmbH
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 40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland) and INexium 40 mg MUPS tablets (AstraZeneca, France) in people with Healthy, run by Mepha Ltd. at 1 site in Germany.
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 7 inclusion and 21 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 23 Jun 2009. 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 Germany. 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?
Comparison of pharmacokinetic parameters of esomeprazole after single oral doses of Esomeprazole Mepha capsules (Test) and 40 mg Esomeprazole INexium MUPS tablets (Reference) under fasted and fed conditions. (time frame: April - June 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2009; AzTrials last refreshed its copy on 1 Nov 2026.