Healthy VolunteersPhase 1NCT01055691
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
A Phase 1 study testing Dapagliflozin/Metformin, Dapagliflozin and Metformin in people with Healthy Volunteers, run by AstraZeneca at 1 site in Germany.
Trial summary
The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dapagliflozin/Metformin, Dapagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Apr 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female healthy volunteers must be post-menopausal (cessation of menses >1year), be surgically sterile (documented) or hysterectomy or on abstinence
- Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values
Who cannot join
- Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
- History of allergy to metformin
- Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State
The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.
- Conditions
- Healthy Volunteers
- Being tested
- Dapagliflozin/Metformin, Dapagliflozin, Metformin
- Keywords
- healthy volunteers, bioequivalence, dapagliflozin, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin/MetforminDrug
Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
DapagliflozinDrug
dapagliflozin tablet 2.5 mg Oral Single dose
MetforminDrug
Also called Glucophage
metformin IR tablet 850 mg Oral Single dose
Dapagliflozin/MetforminDrug
Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
DapagliflozinDrug
dapagliflozin tablet 5 mg Oral Single dose
MetforminDrug
Also called Glucophage
metformin IR tablet 1000 mg Oral Single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet Receives: Drug: Dapagliflozin/Metformin; Drug: Dapagliflozin; Drug: Metformin |
| 2 | Experimental | Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets Receives: Drug: Dapagliflozin/Metformin; Drug: Dapagliflozin; Drug: Metformin |
| 3 | Experimental | Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet Receives: Drug: Dapagliflozin/Metformin; Drug: Dapagliflozin; Drug: Metformin |
| 4 | Experimental | Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets Receives: Drug: Dapagliflozin/Metformin; Drug: Dapagliflozin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
Measured: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
Secondary outcomes (1)
To examine the safety and tolerability of the combination of dapagliflozin and metformin.
Measured: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Georg Golor, M.D., Principal investigator, ParexelThomas Koernicke, Study director, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055691
- Sponsor's protocol ID
- D1691C00002
- Status last verified
- May 2012
- First submitted
- 25 Jan 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State
- ClinicalTrials.gov ID
- NCT01055691
- Acronym / sponsor ID
- D1691C00002
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers, bioequivalence, dapagliflozin, metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Jan 2010 (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 primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dapagliflozin/Metformin, Drug: Dapagliflozin, Drug: MetforminFixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet |
| 2 | Experimental | Drug: Dapagliflozin/Metformin, Drug: Dapagliflozin, Drug: MetforminFree combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets |
| 3 | Experimental | Drug: Dapagliflozin/Metformin, Drug: Dapagliflozin, Drug: MetforminFixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet |
| 4 | Experimental | Drug: Dapagliflozin/Metformin, Drug: Dapagliflozin, Drug: MetforminFree combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female healthy volunteers must be post-menopausal (cessation of menses >1year), be surgically sterile (documented) or hysterectomy or on abstinence
- Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values
Key exclusion criteria (3 listed)
- Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
- History of allergy to metformin
- Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study
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 |
|---|---|---|
| Dapagliflozin/MetforminFixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose | Drug | 1, 2 |
| Dapagliflozindapagliflozin tablet 2.5 mg Oral Single dose | Drug | 1, 2 |
| MetforminAlso: Glucophagemetformin IR tablet 850 mg Oral Single dose | Drug | 1, 2 |
| Dapagliflozin/MetforminFixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose | Drug | 3, 4 |
| Dapagliflozindapagliflozin tablet 5 mg Oral Single dose | Drug | 3, 4 |
| MetforminAlso: Glucophagemetformin IR tablet 1000 mg Oral Single dose | Drug | 3, 4 |
Primary outcome
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
Time frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
1 secondary outcome
To examine the safety and tolerability of the combination of dapagliflozin and metformin.
Time frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)
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 1 Jun 2012.
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Screening Protocol
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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.
Georg Golor, M.D. principal investigator
Parexel
Thomas Koernicke study director
Parexel
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 Dapagliflozin/Metformin, Dapagliflozin and Metformin in people with Healthy Volunteers, run by AstraZeneca 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 2 inclusion and 3 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 1 Jun 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 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?
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin. (time frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.). 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 1 Jun 2012.