Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)Phase 1NCT05266404

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components

A Phase 1 study testing Dapagliflozin/sitagliptin FDC, Sitagliptin and Dapagliflozin in people with Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus), run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
What is being tested?: Dapagliflozin/sitagliptin FDC, Sitagliptin and Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteGermany
Study dates: 21 Mar 2022to 31 May 2022
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

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
Females must have a negative serum pregnancy test at Screening and negative urine pregnancy test within 24 hours prior to investigational Medicinal product (IMP) administration, and must be of non childbearing potential.
Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
Or, if of childbearing potential:
Must not be nursing (breastfeeding).

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If heterosexually active, must agree to consistently use an acceptable method of contraception, to avoid pregnancy from at least 4 weeks prior to the first administration of IMP through 90 days after the last dose of IMP.
Sexually active fertile male subject with partners of childbearing potential must adhere to the contraception methods during the study and until 90 days after the last dose of IMP.
Have a BMI between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Who cannot join

History of any clinically significant disease or disorder which, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
Current or recent (within 3 months of the first IMP dose) gastrointestinal disease that may impact drug absorption and affect the PK of the IMP. Additionally, any gastrointestinal surgery (eg, partial gastrectomy or pyloroplasty), including cholecystectomy, that may impact drug absorption.
Any major surgery within 4 months of the first IMP dose.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of Screening.
Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at Screening) within 4 weeks of the first IMP dose.
Blood transfusion within 4 weeks of the first IMP dose.

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Inability to tolerate oral medication.
Inability to tolerate venipuncture or inadequate venous access.
Recent drug or alcohol abuse.
Excessive intake of alcohol.
Excessive intake of caffeine-containing drinks or food.
Use of tobacco-containing or nicotine-containing products.
History of impaired glucose metabolism.
Recent vulvovaginal mycotic infections (within 2 months prior to first IMP dose).
Any other sound medical, psychiatric, and/or social reason, as determined by the Investigator.
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at Screening and/or admission to the Clinical Unit.
Any clinically significant abnormal findings in vital signs at Screening and/or admission to the Clinical Unit.
Any clinically significant abnormalities on 12-lead ECG at Screening
Any positive result on screening for serum hepatitis B surface antigen or anti-hepatitis core antibody, hepatitis C antibody, and HIV antibody.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first IMP dose in this study.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to dapagliflozin and sitagliptin or to any of the excipients.
Positive screen for drugs of abuse at Screening or on each admission to the Clinical Unit or positive screen for alcohol on each admission to the Clinical Unit.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first IMP dose.
Use of any prescription drugs or OTC acid controllers within 4 weeks prior to the first IMP dose. Use of any prescribed or non-prescribed medication including analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins, and minerals during the 2 weeks prior to the first IMP dose or longer if the medication has a long half-life.
Subjects who have previously received dapagliflozin or sitagliptin.
Subjects who had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
Subjects who had the last dose of the COVID-19 vaccine within 7 days of Screening.
Recent (within 14 days prior to Screening) exposure to someone who has COVID 19 symptoms or positive test results for COVID-19.
Recent (within 14 days prior to Screening) visit to a healthcare facility where patients with COVID-19 are being treated.
Subjects who are regularly exposed to COVID-19 as part of their daily life (eg, health care professionals working in COVID-19 wards or at emergency departments).
Subjects who have positive test results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via reverse transcriptase polymerase chain reaction (RT-PCR) before randomization.
Subject has clinical signs and symptoms consistent with COVID-19 infection or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
Involvement of any AstraZeneca, Parexel, or study site employee or their close relatives.
Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during Screening) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
Subjects who cannot communicate reliably with the Investigator.
Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tablets in Healthy Subjects

Read the detailed description

This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, crossover study in healthy subjects (males and females), performed at a single study center. The study will assess the bioequivalence between a dapagliflozin/sitagliptin FDC tablet (test formulation) and a free combination of dapagliflozin 10 mg + sitagliptin 100 mg co-administered as individual tablets (reference formulation) in fasted conditions to healthy subjects. The study will also assess the Pharmacokinetics (PK) and safety and tolerability of dapagliflozin 10 mg and sitagliptin 100 mg when co-administered as individual tablets and as an FDC tablet.

The study will comprise:

A Screening Period of maximum 28 days.
Two Treatment Periods (Treatment A or B)
A final Safety Follow-up Visit 7 to 14 days after the last dosing with the Investigational medicinal product (IMP) (Treatment A or B).

There will be a minimum washout period of 7 days and a maximum of 14 days between each treatment period.

All subjects will receive a single dose of the following treatments after an overnight fast of 10 hours:

Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation).
Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).

Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by Treatment B or Treatment B followed by Treatment A.

Conditions: Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Being tested: Dapagliflozin/sitagliptin FDC, Sitagliptin, Dapagliflozin
Keywords: Sodium-glucose co-transporter-2 (SGLT2) inhibitor, Dipeptidyl peptidase 4 (DPP4) inhibitor, fixed dose combination (FDC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dapagliflozin/sitagliptin FDCDrug
Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.
SitagliptinDrug
Also called JANUVIA™
Subjects will receive 100 mg single dose of Sitagliptin orally.
DapagliflozinDrug
Also called FORXIGA™
Subjects will receive 10 mg single dose of Dapagliflozin orally.

Study groups in NCT05266404
Study group	Role	What they receive
Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tablet	Experimental	Subjects will receive single dose of dapagliflozin/sitagliptin fixed dose combination (FDC) (test formulation). Receives: Drug: Dapagliflozin/sitagliptin FDC
Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin	Active comparator	Subjects will receive single dose of dapagliflozin 10 mg tablet + sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation). Receives: Drug: Sitagliptin; Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under plasma concentration-time curve from zero to infinity (AUCinf)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Maximum observed plasma (peak) drug concentration (Cmax)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F)
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Measured: Day 1, Day 2, Day 3 and Day 4

Secondary outcomes (10)

Area under plasma concentration-time curve from zero to infinity (AUCinf)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F)
To characterize the PK profiles of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects in a fasted state.
Measured: Day 1, Day 2, Day 3 and Day 4
Number of subjects with adverse events (AEs)
To assess the safety and tolerability of single doses of a dapagliflozin/sitagliptin FDC tablet and dapagliflozin 10 mg + sitagliptin 100 mg when co-administered as individual tablets in healthy subjects.
Measured: From screening (Day -28) to Safety Follow-up (7 to 14 days after the last dosing with the IMP) [up to 66 days]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202231 May 2022

First posted4 Mar 2022
Study start21 Mar 2022
Primary completion31 May 2022
Study completion31 May 2022

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 Volunteers (Intended Indication: Type 2 Diabetes Mellitus)Studies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05266404
Sponsor's protocol ID: D1683C00014
Other IDs: 2021-005104-35
Status last verified: Jun 2022
First submitted: 23 Feb 2022
Last updated: 5 Jul 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Lukka PB, Tang W, Hammarstedt A, Conrad T, Heijer M, Karlsson C, Boulton DW. Racial Comparison of the Pharmacokinetics and Safety of Fixed-dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. Clin Ther. 2024 Sep;46(9):717-725. doi: 10.1016/j.clinthera.2024.07.007. Epub 2024 Aug 23.
PubMed 39179458

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT05266404
Acronym / sponsor ID: D1683C00014
Conditions: Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Keywords: Sodium-glucose co-transporter-2 (SGLT2) inhibitor, Dipeptidyl peptidase 4 (DPP4) inhibitor, fixed dose combination (FDC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 21 Mar 2022 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 4 Mar 2022 (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.

Detailed description

The study will comprise:

A Screening Period of maximum 28 days.
Two Treatment Periods (Treatment A or B)
A final Safety Follow-up Visit 7 to 14 days after the last dosing with the Investigational medicinal product (IMP) (Treatment A or B).

There will be a minimum washout period of 7 days and a maximum of 14 days between each treatment period.

All subjects will receive a single dose of the following treatments after an overnight fast of 10 hours:

Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation).
Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).

Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by Treatment B or Treatment B followed by Treatment A.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tablet	Experimental	Drug: Dapagliflozin/sitagliptin FDCSubjects will receive single dose of dapagliflozin/sitagliptin fixed dose combination (FDC) (test formulation).
Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin	Active comparator	Drug: Sitagliptin, Drug: DapagliflozinSubjects will receive single dose of dapagliflozin 10 mg tablet + sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
Females must have a negative serum pregnancy test at Screening and negative urine pregnancy test within 24 hours prior to investigational Medicinal product (IMP) administration, and must be of non childbearing potential.
Sexually active fertile male subject with partners of childbearing potential must adhere to the contraception methods during the study and until 90 days after the last dose of IMP.
Have a BMI between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Key exclusion criteria (36 listed)

History of any clinically significant disease or disorder which, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
Current or recent (within 3 months of the first IMP dose) gastrointestinal disease that may impact drug absorption and affect the PK of the IMP. Additionally, any gastrointestinal surgery (eg, partial gastrectomy or pyloroplasty), including cholecystectomy, that may impact drug absorption.
Any major surgery within 4 months of the first IMP dose.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of Screening.
Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at Screening) within 4 weeks of the first IMP dose.

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/sitagliptin FDCSubjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.	Drug	Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tablet
SitagliptinAlso: JANUVIA™Subjects will receive 100 mg single dose of Sitagliptin orally.	Drug	Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin
DapagliflozinAlso: FORXIGA™Subjects will receive 10 mg single dose of Dapagliflozin orally.	Drug	Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin

Primary outcome

Area under plasma concentration-time curve from zero to infinity (AUCinf)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F)
Time frame: Day 1, Day 2, Day 3 and Day 4
To demonstrate the fasted-state bioequivalence between a dapagliflozin/sitagliptin FDC tablet relative to dapagliflozin 10 mg + sitagliptin 100 mg when co administered as individual tablets in healthy subjects.

10 secondary outcomes

Area under plasma concentration-time curve from zero to infinity (AUCinf)
Time frame: Day 1, Day 2, Day 3 and Day 4
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2, Day 3 and Day 4
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1, Day 2, Day 3 and Day 4
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Time frame: Day 1, Day 2, Day 3 and Day 4
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Day 1, Day 2, Day 3 and Day 4
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Time frame: Day 1, Day 2, Day 3 and Day 4
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time frame: Day 1, Day 2, Day 3 and Day 4
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Day 1, Day 2, Day 3 and Day 4
Volume of distribution (apparent) following extravascular administration (based on terminal phase) (Vz/F)
Time frame: Day 1, Day 2, Day 3 and Day 4
Number of subjects with adverse events (AEs)
Time frame: From screening (Day -28) to Safety Follow-up (7 to 14 days after the last dosing with the IMP) [up to 66 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 5 Jul 2022.
Derived from this study: PubMed 39179458Lukka PB, Tang W, Hammarstedt A, Conrad T, Heijer M, Karlsson C, Boulton DW. Racial Comparison of the Pharmacokinetics and Safety of Fixed-dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. Clin Ther. 2024 Sep;46(9):717-725. doi: 10.1016/j.clinthera.2024.07.007. Epub 2024 Aug 23.
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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?

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 9 inclusion and 36 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 5 Jul 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 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?

Area under plasma concentration-time curve from zero to infinity (AUCinf) (time frame: Day 1, Day 2, Day 3 and Day 4). The study lists 9 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 NCT05266404, 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 5 Jul 2022.