Bioequivalence StudyPhase 1NCT01595425
Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects
A Phase 1 study testing D961H Sachet 20 mg and D961H HPMC capsule 20 mg in people with Bioequivalence Study, run by AstraZeneca at 1 site in Japan.
Trial summary
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects. 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
- Bioequivalence Study
- 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
- 71 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Jun 2012
- 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
- Japanese healthy male subjects aged 20 to 45 years of age
- Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
- Clinically normal findings
- Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19
Who cannot join
- Significant clinical illness
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- Clinical significant condition which could modify the absorption of the investigational product
- Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.
Read the detailed description
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
- Conditions
- Bioequivalence Study
- Being tested
- D961H Sachet 20 mg, D961H HPMC capsule 20 mg
- Keywords
- Bioequivalence,, pharmacokinetics,, safety,, esomeprazole,, Japanese,, healthy subject,, homo-EM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D961H Sachet 20 mgDrug
Also called esomeprazole sachet
Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.
D961H HPMC capsule 20 mgDrug
Also called esomeprazole, capsule 20 mg
Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| D961H Sachet 20 mg | Experimental | 2 way crossover Receives: Drug: D961H Sachet 20 mg |
| D961HHPMC Capsule 20 mg | Experimental | 2 way crossover Receives: Drug: D961H HPMC capsule 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ and Cmax,ss of D961H
- AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration
- Cmax,ss - maximum concentration at steady state
Measured: Day 5
Secondary outcomes (3)
Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.
- AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state
- MRT- Mean residence time
- tmax,ss -time of maximum concentration at steady state
- t½ -Terminal half-life
Measured: Day 5
Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.
Measured: Up to 5 to 7 days after the last dose.
Number of participants with adverse events.
Measured: Up to 5 to 7 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masataka Date, Study director, AstraZeneca R&D JapanMasanari Shiramoto, Principal investigator, Hakata Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595425
- Sponsor's protocol ID
- D961TC00001
- Status last verified
- Dec 2012
- First submitted
- 8 May 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01595425
- Acronym / sponsor ID
- D961TC00001
- Conditions
- Bioequivalence Study
- Keywords
- Bioequivalence,, pharmacokinetics,, safety,, esomeprazole,, Japanese,, healthy subject,, homo-EM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 May 2012 (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.
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.
Detailed description
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
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 mg2 way crossover |
| D961HHPMC Capsule 20 mg | Experimental | Drug: D961H HPMC capsule 20 mg2 way crossover |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years of age
- Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
- Clinically normal findings
- Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19
Key exclusion criteria (4 listed)
- Significant clinical illness
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- Clinical significant condition which could modify the absorption of the investigational product
- Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention
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 mgAlso: esomeprazole sachetEach volunteer will receive a D961H sachet 20 mg once in the morning for 5 days. | Drug | D961H Sachet 20 mg |
| D961H HPMC capsule 20 mgAlso: esomeprazole, capsule 20 mgEach volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days. | Drug | D961HHPMC Capsule 20 mg |
Primary outcome
AUCτ and Cmax,ss of D961H
Time frame: Day 5
* AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration * Cmax,ss - maximum concentration at steady state
3 secondary outcomes
Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.
Time frame: Day 5
Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.
Time frame: Up to 5 to 7 days after the last dose.
Number of participants with adverse events.
Time frame: Up to 5 to 7 days after the last 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 12 Dec 2012.
Related trials for Bioequivalence Study
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
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
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.
Masataka Date study director
AstraZeneca R&D Japan
Masanari Shiramoto principal investigator
Hakata Clinic
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 D961H Sachet 20 mg and D961H HPMC capsule 20 mg in people with Bioequivalence Study, run by AstraZeneca at 1 site 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 5 inclusion and 4 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 12 Dec 2012. 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 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?
AUCτ and Cmax,ss of D961H (time frame: Day 5). 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 12 Dec 2012.