Bioequivalence StudyPhase 1NCT01494402
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
A Phase 1 study testing D961S, Esomeprazole and Buffered acetylsalicylic acid in people with Bioequivalence Study, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration 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?
- D961S, Esomeprazole and Buffered acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Mar 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
- Healthy Japanese males 20-45 years of age
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
Who cannot join
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- Need for concomitant medication in the study
- Past or present NSAIDs induced asthma
- History of bleeding diathesis
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 D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.
Read the detailed description
A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
- Conditions
- Bioequivalence Study
- Being tested
- D961S, Esomeprazole, Buffered acetylsalicylic acid
- Keywords
- Healthy volunteer, Japanese males, homo-EM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D961SDrug
Oral gelatine capsule
EsomeprazoleDrug
Also called Nexium® capsule 20 mg
Oral HPMC capsule
Buffered acetylsalicylic acidDrug
Also called Bufferin Combination Tablet A81
Tablet
| Study group | Role | What they receive |
|---|---|---|
| D961S | Experimental | 2 way crossover Receives: Drug: D961S |
| esomeprazole + buffered acetylsalicylic acid | Experimental | 2 way crossover Receives: Drug: Esomeprazole; Drug: Buffered acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Measured: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Measured: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Secondary outcomes (2)
Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA
All PK variables and plasma concentrations of esomeprazole, ASA and SA at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Measured: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.
Descriptive statistics will be provided for all safety variables, and the analyses will be performed according to the actual treatment. No formal comparison will be performed.
Measured: Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494402
- Sponsor's protocol ID
- D961SC00001
- Status last verified
- Apr 2012
- First submitted
- 15 Dec 2011
- Last updated
- 9 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 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 D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01494402
- Acronym / sponsor ID
- D961SC00001
- Conditions
- Bioequivalence Study
- Keywords
- Healthy volunteer, Japanese males, homo-EM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Dec 2011 (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 assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.
Detailed description
A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 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 |
|---|---|---|
| D961S | Experimental | Drug: D961S2 way crossover |
| esomeprazole + buffered acetylsalicylic acid | Experimental | Drug: Esomeprazole, Drug: Buffered acetylsalicylic acid2 way crossover |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Japanese males 20-45 years of age
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
Key exclusion criteria (5 listed)
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- Need for concomitant medication in the study
- Past or present NSAIDs induced asthma
- History of bleeding diathesis
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 |
|---|---|---|
| D961SOral gelatine capsule | Drug | D961S |
| EsomeprazoleAlso: Nexium® capsule 20 mgOral HPMC capsule | Drug | esomeprazole + buffered acetylsalicylic acid |
| Buffered acetylsalicylic acidAlso: Bufferin Combination Tablet A81Tablet | Drug | esomeprazole + buffered acetylsalicylic acid |
Primary outcome
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
Time frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)
Time frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
2 secondary outcomes
Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA
Time frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.
Time frame: Pre-entry, Day 5 of treatment period and follow up (5-7 days after 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 9 Apr 2012.
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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?
A Phase 1 study testing D961S, Esomeprazole and Buffered acetylsalicylic acid 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 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 9 Apr 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?
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ). (time frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6). The study lists 2 primary outcomes in all. 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 9 Apr 2012.