CompletedPhase 1

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.

China80 participantsStarted 2021-04-12

Plain-language summary

To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the plasma concentration-time curve from zero to the last quantifiable concentration(AUClast) of dapagliflozin and metformin.

Timeframe: 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.

Timeframe: 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.

Timeframe: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.

Trial details

NCT IDNCT04856007

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-14

View on ClinicalTrials.gov More Healthy Volunteer trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

What they're measuring

Area under the plasma concentration-time curve from zero to the last quantifiable concentration(AUClast) of dapagliflozin and metformin.

Timeframe: 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.

Timeframe: 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.

Timeframe: From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days.