Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and MetforminPhase 1NCT01441869
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
A Phase 1 study testing Onglyza (saxagliptin), Diabex and 5-mg saxagliptin/1000 mg metformin in people with Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin, run by AstraZeneca at 1 site in United States.
Trial summary
Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
- What is being tested?
- Onglyza (saxagliptin), Diabex and 5-mg saxagliptin/1000 mg metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent prior to any study specific procedures
- Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive
- Females must have a negative urine pregnancy test at screening and negative serum pregnancy test on admission to the unit, must not be lactating, and must be using an acceptable method of contraception for at least 1 month before dosing
- Female volunteers of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year
- Oral contraceptive and hormone replacement medications are allowed in this study if used together with a barrier contraceptive method.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- Glomerular filtration rate of less than 60 mL/min (to be estimated at screening only)
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator (eg, seasonal allergies) or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin or metformin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.
Read the detailed description
Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
- Being tested
- Onglyza (saxagliptin), Diabex, 5-mg saxagliptin/1000 mg metformin, 5-mg saxagliptin/500 mg metformin
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, saxagliptin/ metformin , Diabex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onglyza (saxagliptin)Drug
Oral tablets, 5 mg , single dose
DiabexDrug
Extended release oral tablets, 1000 mg, single dose
5-mg saxagliptin/1000 mg metforminDrug
Extended release fixed dose combination tablet, single dose
DiabexDrug
Extended release oral tablets, 500 mg, single dose
5-mg saxagliptin/500 mg metforminDrug
Extended release fixed dose combination tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet Receives: Drug: Onglyza (saxagliptin); Drug: Diabex |
| B | Experimental | 5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet Receives: Drug: Onglyza (saxagliptin); Drug: 5-mg saxagliptin/1000 mg metformin |
| C | Experimental | 5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet Receives: Drug: Diabex |
| D | Experimental | 5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet Receives: Drug: 5-mg saxagliptin/500 mg metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Measured: At day 5 to day 6 at visit 2 or 3
PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Measured: At day 5 to day 6 at visit 2 or 3
Secondary outcomes (2)
PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Measured: At day 5 to day 6 at visit 2 or 3
Safety will be assessed by the incidence, severity, and relatedness of adverse events.
Measured: From day -1 visit 2 until performed follow up ( Approximately 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and MetforminStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miriana Kujacic, MD, Study chair, AstraZeneca Mölndal, SwedenPhil Leese, MD, Principal investigator, Quintiles, Inc. Overland Park USPeter Öhman, MD, Study director, Astrazeneca, Wilmington, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441869
- Sponsor's protocol ID
- D1681C00004
- Status last verified
- Feb 2012
- First submitted
- 26 Sep 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
- ClinicalTrials.gov ID
- NCT01441869
- Acronym / sponsor ID
- D1681C00004
- Keywords
- Phase 1, Healthy male volunteers, pharmacokinetics, saxagliptin/ metformin , Diabex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Sep 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.
Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.
Detailed description
Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Onglyza (saxagliptin), Drug: Diabex5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet |
| B | Experimental | Drug: Onglyza (saxagliptin), Drug: 5-mg saxagliptin/1000 mg metformin5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet |
| C | Experimental | Drug: Diabex5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet |
| D | Experimental | Drug: 5-mg saxagliptin/500 mg metformin5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent prior to any study specific procedures
- Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive
- Females must have a negative urine pregnancy test at screening and negative serum pregnancy test on admission to the unit, must not be lactating, and must be using an acceptable method of contraception for at least 1 month before dosing
- Female volunteers of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year
- Oral contraceptive and hormone replacement medications are allowed in this study if used together with a barrier contraceptive method.
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- Glomerular filtration rate of less than 60 mL/min (to be estimated at screening only)
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator (eg, seasonal allergies) or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin or metformin
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 |
|---|---|---|
| Onglyza (saxagliptin)Oral tablets, 5 mg , single dose | Drug | A, B |
| DiabexExtended release oral tablets, 1000 mg, single dose | Drug | A |
| 5-mg saxagliptin/1000 mg metforminExtended release fixed dose combination tablet, single dose | Drug | B |
| DiabexExtended release oral tablets, 500 mg, single dose | Drug | C |
| 5-mg saxagliptin/500 mg metforminExtended release fixed dose combination tablet, single dose | Drug | D |
Primary outcome
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
2 secondary outcomes
PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
Safety will be assessed by the incidence, severity, and relatedness of adverse events.
Time frame: From day -1 visit 2 until performed follow up ( Approximately 30 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 8 Feb 2012.
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.
Miriana Kujacic, MD study chair
AstraZeneca Mölndal, Sweden
Phil Leese, MD principal investigator
Quintiles, Inc. Overland Park US
Peter Öhman, MD study director
Astrazeneca, Wilmington, US
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 Onglyza (saxagliptin), Diabex and 5-mg saxagliptin/1000 mg metformin in people with Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin, run by AstraZeneca at 1 site in United States.
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 8 Feb 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 United States. 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?
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) (time frame: At day 5 to day 6 at visit 2 or 3). 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 8 Feb 2012.