Healthy VolunteerPhase 1NCT04856007
A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
A Phase 1 study testing Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg and Dapagliflozin 5 mg + Metformin 500 mg XR in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
Trial summary
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg and Dapagliflozin 5 mg + Metformin 500 mg XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 14 Jun 2021
- 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 informed consent prior to any study specific procedures.
- Healthy Chinese subjects as determined by no clinically significant deviation from normal in medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory evaluations.
- Male or female, ages 18 to 55 years, inclusive, at the time of signing the informed consent
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and <26 kg/m2. BMI = weight (kg)/[height (m)]2.
- Female participants: Women of childbearing potential must use one highly effective form of birth control.
- Must be able to communicate with the investigator, understand and comply with all study requirements.
Who cannot join
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months prior to study drug administration) gastrointestinal disease that may impact drug absorption and affect PK of the study drugs. Additionally, any gastrointestinal surgery (eg, partial gastrectomy, pyloroplasty) that could impact the absorption of study drug.
- Any major surgery, as determined by the investigator, within 4 weeks prior to study drug administration.
- Donation of blood within 3 months prior to study drug administration.
- Blood transfusion within 4 weeks prior to study drug administration.
- Inability to tolerate oral medication.
Show all 34Show fewer
- Inability to tolerate venous access.
- Drug or alcohol abuse within 6 months prior to study drug administration. Alcohol abuse is defined as a history of regular alcohol consumption exceeding 14 drinks per week, or a positive breath alcohol test at screening and/or check-in. 1 drink equals to 5 ounces (150ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor.
- Regularly drink more than 3 cups of coffee or other caffeine-containing products a day, or 5 cups of tea a day.
- Regular smoker (the subject should be able to abstain from smoking for the duration of the study without having abstinence, therefore they should not be regular smokers, regular smokers are defined as people who smoke everyday), use of tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 4 weeks prior to study drug administration .
- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Any of the following on ECG prior to study drug administration:
- PR≥210ms
- QRS≥120ms
- QT≥500ms
- QTcF≥450ms(male) or QTcF≥470ms(female)
- Positive urine screen for drugs of abuse.
- Any clinically significant abnormal findings in urinalysis (may repeat once) at screening, as judged by the investigator.
- Glucosuria at screening.
- Abnormal liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or total bilirubin > 10% above upper limit of normal [ULN]).
- Elevated serum creatinine (> ULN).
- Positive blood screen for HIV antibody , Syphilis antibody, hepatitis C antibody , or Hepatitis B surface antigen (HbsAg) or only Hepatitis B core antibody (anti-HBc) in Hepatitis B serologic test.
- History of allergy to SGLT2 inhibitor drug class or related compounds.
- History of allergy or intolerance to metformin or other similar acting agents.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Prior exposure to metformin or dapagliflozin within 3 months of study drug administration.
- Exposure to any investigational product or placebo within 4 weeks prior to study drug administration.
- Use of any prescription drugs or over-the counter (OTC), traditional Chinese medicine and herbal preparations within 4 weeks prior to study drug administration.
- Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff or staff at the study site).
- Previous enrolled or randomized in the present study.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Has clinical signs and symptoms consistent with COVID-19 infection (eg fever, dry cough, dyspnea, sore throat, fatigue.. etc) as judged by investigator or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
- History of COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
Read the detailed description
A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
- Conditions
- Healthy Volunteer
- Being tested
- Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg, Dapagliflozin 5 mg + Metformin 500 mg XR, Dapagliflozin 10 mg + Metformin 1000 mg XR
- Keywords
- Dapagliflozin, Forxiga, Metformin XR, Glucophage XR, Xigduo XR, Bioequivalence, Cross-over
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin/metformin XR FDC 5/500 mgDrug
Also called Xigduo XR
In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.
Dapagliflozin/metformin XR FDC 10/1000 mgDrug
Also called Xigduo XR
In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.
Dapagliflozin 5 mg + Metformin 500 mg XRDrug
Also called Forxiga + Glucophage XR
In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.
Dapagliflozin 10 mg + Metformin 1000 mg XRDrug
Also called Forxiga + Glucophage XR
In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 5mg + Metformin 500mg XR | Experimental | co-administration of a single oral dose of a 5mg dapagliflozin (Forxiga® 5mg) tablet and a 500mg metformin XR (Glucophage XR®) tablet Receives: Drug: Dapagliflozin/metformin XR FDC 5/500 mg |
| Dapagliflozin/metformin XR FDC 5/500 mg | Experimental | single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR subject Receives: Drug: Dapagliflozin 5 mg + Metformin 500 mg XR |
| Dapagliflozin 10mg + Metformin 1000mg XR | Experimental | co-administration of a single oral dose of a 10mg dapagliflozin (Forxiga® 10mg) tablet and two 500mg metformin XR (Glucophage XR®) tablets Receives: Drug: Dapagliflozin/metformin XR FDC 10/1000 mg |
| Dapagliflozin/metformin XR FDC 10/1000 mg | Experimental | ingle FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR Receives: Drug: Dapagliflozin 10 mg + Metformin 1000 mg XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to the last quantifiable concentration(AUClast) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Area under the plasma concentration-time curve from zero to infinity (AUCinf) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Maximum observed plasma concentration (Cmax) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Secondary outcomes (5)
Time to maximum observed plasma concentration (tmax) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Terminal elimination rate constant (λz) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve(t½λz) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Apparent volume of distribution following extravascular administration (Vz/F) of dapagliflozin and metformin.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Measured: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start12 Apr 2021
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There will be two independent cohorts of subjects who will each receive two treatments in a randomized order, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP in order to complete at least 36 evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, MD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856007
- Sponsor's protocol ID
- D1691C00011
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Publications
Zhao X, Ning R, Hui A, Boulton DW, Tang W. Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-release Fixed-dose Combination in Healthy Chinese Volunteers and Regional Comparison. Clin Ther. 2023 Aug;45(8):762-769. doi: 10.1016/j.clinthera.2023.06.012. Epub 2023 Jul 11.
PubMed 37442656
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
- ClinicalTrials.gov ID
- NCT04856007
- Acronym / sponsor ID
- D1691C00011
- Conditions
- Healthy Volunteer
- Keywords
- Dapagliflozin, Forxiga, Metformin XR, Glucophage XR, Xigduo XR, Bioequivalence, Cross-over
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- 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.
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
Detailed description
A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be two independent cohorts of subjects who will each receive two treatments in a randomized order, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP in order to complete at least 36 evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 5mg + Metformin 500mg XR | Experimental | Drug: Dapagliflozin/metformin XR FDC 5/500 mgco-administration of a single oral dose of a 5mg dapagliflozin (Forxiga® 5mg) tablet and a 500mg metformin XR (Glucophage XR®) tablet |
| Dapagliflozin/metformin XR FDC 5/500 mg | Experimental | Drug: Dapagliflozin 5 mg + Metformin 500 mg XRsingle FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR subject |
| Dapagliflozin 10mg + Metformin 1000mg XR | Experimental | Drug: Dapagliflozin/metformin XR FDC 10/1000 mgco-administration of a single oral dose of a 10mg dapagliflozin (Forxiga® 10mg) tablet and two 500mg metformin XR (Glucophage XR®) tablets |
| Dapagliflozin/metformin XR FDC 10/1000 mg | Experimental | Drug: Dapagliflozin 10 mg + Metformin 1000 mg XRingle FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of informed consent prior to any study specific procedures.
- Healthy Chinese subjects as determined by no clinically significant deviation from normal in medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory evaluations.
- Male or female, ages 18 to 55 years, inclusive, at the time of signing the informed consent
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and <26 kg/m2. BMI = weight (kg)/[height (m)]2.
- Female participants: Women of childbearing potential must use one highly effective form of birth control.
Key exclusion criteria (34 listed)
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months prior to study drug administration) gastrointestinal disease that may impact drug absorption and affect PK of the study drugs. Additionally, any gastrointestinal surgery (eg, partial gastrectomy, pyloroplasty) that could impact the absorption of study drug.
- Any major surgery, as determined by the investigator, within 4 weeks prior to study drug administration.
- Donation of blood within 3 months prior to study drug administration.
- Blood transfusion within 4 weeks prior to study drug administration.
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/metformin XR FDC 5/500 mgAlso: Xigduo XRIn cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. | Drug | Dapagliflozin 5mg + Metformin 500mg XR |
| Dapagliflozin/metformin XR FDC 10/1000 mgAlso: Xigduo XRIn cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. | Drug | Dapagliflozin 10mg + Metformin 1000mg XR |
| Dapagliflozin 5 mg + Metformin 500 mg XRAlso: Forxiga + Glucophage XRIn cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. | Drug | Dapagliflozin/metformin XR FDC 5/500 mg |
| Dapagliflozin 10 mg + Metformin 1000 mg XRAlso: Forxiga + Glucophage XRIn cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. | Drug | Dapagliflozin/metformin XR FDC 10/1000 mg |
Primary outcome
Area under the plasma concentration-time curve from zero to the last quantifiable concentration(AUClast) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Area under the plasma concentration-time curve from zero to infinity (AUCinf) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
Maximum observed plasma concentration (Cmax) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
For period 1 and 2, PK samples will be collected pre-dose and 0.5,1,2,3,4,6,8,10,12,24(Day2),36,48(Day3), and 72(Day4) hours post dose.
5 secondary outcomes
Time to maximum observed plasma concentration (tmax) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Terminal elimination rate constant (λz) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve(t½λz) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.
Apparent volume of distribution following extravascular administration (Vz/F) of dapagliflozin and metformin.
Time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 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 29 Apr 2022.
- Derived from this study: PubMed 37442656Zhao X, Ning R, Hui A, Boulton DW, Tang W. Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-release Fixed-dose Combination in Healthy Chinese Volunteers and Regional Comparison. Clin Ther. 2023 Aug;45(8):762-769. doi: 10.1016/j.clinthera.2023.06.012. Epub 2023 Jul 11.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
Liyan Miao, MD principal investigator
The First Affiliated Hospital of Soochow University
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 XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg and Dapagliflozin 5 mg + Metformin 500 mg XR in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
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 6 inclusion and 34 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 29 Apr 2022. 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 China. 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?
Area under the plasma concentration-time curve from zero to the last quantifiable concentration(AUClast) of dapagliflozin and metformin. (time frame: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856007, which also lists 1 linked publication.
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 29 Apr 2022.