Gastric UlcerPhase 1NCT01964131
BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
A Phase 1 study testing D961H sachet 20 mg and D961H HPMC capsule 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 2 sites in Japan.
Trial summary
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer
- What is being tested?
- D961H sachet 20 mg and D961H HPMC capsule 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2013to Dec 2013
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy Japanese male subjects between 20 and 45 years of age
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
- Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
- Clinically normal findings at the enrolment medical examination, as judged by the investigator(s)
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- Homo-EM according to the genotype of CYP2C19
- Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording
- Helicobacter pylori negative has been known by urea breath test as the volunteer panel data
Who cannot join
- Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
- Past or present drug addiction or alcohol abuse
- Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
- Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
- Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach
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- Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation)
- Need for concomitant medication in the study
- Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor
- Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1
- Administration of any investigational product within 4 months preceding the pre-entry visit
- Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site)
- Clinical judgment by the investigator(s) that the subject should not participate in the study
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Hakata Clinic Medical Co. LTA
Fukuoka, Fukuoka, 812-0025
Research Site
Fukuoka, Fukuoka
About this study
Official title: An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
Read the detailed description
The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Esophagitis, Etc.
- Being tested
- D961H sachet 20 mg, D961H HPMC capsule 20 mg
- Keywords
- Bioequivalence, pharmacodynamics, pharmacokinetics, safety, tolerability, D961H, Japanese
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D961H sachet 20 mgDrug
Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)".
Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
D961H HPMC capsule 20 mgDrug
Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
| Study group | Role | What they receive |
|---|---|---|
| D961H sachet 20 mg | Experimental | Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets Receives: Drug: D961H sachet 20 mg |
| D961H HPMC capsule 20 mg | Other | Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule Receives: Drug: D961H HPMC capsule 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg
To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
Measured: 27 days
Secondary outcomes (3)
Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
Measured: 27 days
Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
Measured: 27 days
Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megumi Inoue, MD, PhD, Principal investigator, Hakata Clinic Medical Co. LTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964131
- Sponsor's protocol ID
- D961TC00004
- Status last verified
- Dec 2013
- First submitted
- 14 Oct 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01964131
- Acronym / sponsor ID
- D961TC00004
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Esophagitis, Etc.
- Keywords
- Bioequivalence, pharmacodynamics, pharmacokinetics, safety, tolerability, D961H, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2013 (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 purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
Detailed description
The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D961H sachet 20 mg | Experimental | Drug: D961H sachet 20 mgPellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets |
| D961H HPMC capsule 20 mg | Other | Drug: D961H HPMC capsule 20 mgPellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy Japanese male subjects between 20 and 45 years of age
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
- Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
Key exclusion criteria (13 listed)
- Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
- Past or present drug addiction or alcohol abuse
- Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
- Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
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 |
|---|---|---|
| D961H sachet 20 mgEach subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg | Drug | D961H sachet 20 mg |
| D961H HPMC capsule 20 mgEach subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg | Drug | D961H HPMC capsule 20 mg |
Primary outcome
Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg
Time frame: 27 days
To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
3 secondary outcomes
Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH
Time frame: 27 days
Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
Time frame: 27 days
Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
Time frame: 34 days
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 31 Dec 2013.
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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.
Megumi Inoue, MD, PhD principal investigator
Hakata Clinic Medical Co. LTA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D961H sachet 20 mg and D961H HPMC capsule 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 2 sites in Japan.
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 9 inclusion and 13 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg (time frame: 27 days). 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 31 Dec 2013.