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Bioequivalence Study of Dapagliflozin 10 mg Tablets in Healthy Adult Volunteers with Diabetes

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves the condition known as diabetes and examines two versions of a medication that contains the active ingredient Dapagliflozin. One version is a tablet made by Sun Pharmaceutical Industries, and the other is the brand‑name product Forxiga, both delivering a 10 mg dose taken by mouth.

The purpose is to determine whether the two tablets deliver the same amount of medication to the body, a concept called bioequivalence. Healthy adult volunteers will take one tablet after an overnight fast, have blood drawn at several times to measure the drug level, then, after a short break, will take the other tablet and undergo the same blood‑sampling process. The study follows a simple, step‑by‑step schedule without any complex procedures.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and sequence assignment

    After you join the study, you will be randomly assigned to one of two possible sequences. the sequence determines whether you receive the test product first and the reference product later, or the opposite.

  2. Step 2

    Fasting before the first dose

    You will be asked to fast, meaning no food or drink (except water) for several hours before taking the study medication. this ensures consistent absorption of the drug.

  3. Step 3

    First single dose administration

    You will take one tablet containing 10 mg of dapagliflozin. the tablet will be swallowed with a small amount of water while you are still fasting.

  4. Step 4

    Post‑dose fasting period

    After the tablet is taken, you will continue to fast for the time specified by the study staff. this helps keep the conditions the same for all participants.

  5. Step 5

    Blood sample collection (first period)

    Blood samples will be drawn at several time points after the dose. the samples are used to measure the concentration of dapagliflozin in your blood, which is needed to evaluate bioequivalence.

  6. Step 6

    Washout period

    A washout period will follow the first set of samples. during this time no study medication is taken, allowing the drug to be cleared from your body before the next dose.

  7. Step 7

    Fasting before the second dose

    You will again fast for the required number of hours before receiving the second tablet.

  8. Step 8

    Second single dose administration

    You will take the other tablet, also containing 10 mg of dapagliflozin. if you received the test product first, this will be the reference product, and vice versa.

  9. Step 9

    Post‑dose fasting period (second dose)

    As with the first dose, you will continue to fast for the prescribed period after swallowing the tablet.

  10. Step 10

    Blood sample collection (second period)

    Additional blood samples will be taken at multiple time points after the second dose. these measurements are compared with the first set to determine if the two products are bioequivalent.

  11. Step 11

    Completion of study procedures

    After the second series of samples is collected, all study activities are finished. no further medication will be taken as part of the trial.

Who can join the trial?

6 criteria

  • Healthy male or female volunteer aged 18 to 45 years (inclusive).
  • Must follow a non‑vegetarian diet (includes meat, fish, or poultry).
  • Body mass index (BMI) must be between 18.5 and 29.0 kg/m² (BMI is a number that compares weight to height).
  • Must give written informed consent, meaning you agree to join after understanding the study.
  • All screening procedures (medical checks) must be done within 28 days before the first dose.
  • If female, you must be non‑pregnant and non‑lactating, and use an effective birth control method (e.g., condom, diaphragm, non‑hormonal IUD, abstinence) or be surgically sterile or postmenopausal for at least 2 years.

Who cannot join the trial?

18 criteria

  • Allergic reactions to dapagliflozin or any oral diabetes medicines will exclude you.
  • Any psychiatric illness (mental health disorder) will exclude you.
  • People who regularly smoke more than 5 cigarettes a day cannot participate.
  • Habitual drug dependence or drinking more than 2 units of alcohol per day (one unit equals about 500 mL beer, 200 mL wine, or 50 mL distilled spirits) will exclude you.
  • Use of any medicine or supplement that increases the breakdown of the study drug within 28 days before dosing, or that slows the breakdown within 14 days before dosing, will exclude you.
  • Use of any other investigational drug in a clinical trial within 12 weeks before dosing will exclude you.
  • Having donated blood or experienced a significant blood loss of 400 mL or more within 12 weeks before dosing will exclude you.
  • A positive urine test for illegal drugs at screening will exclude you.
  • A positive pregnancy test (urine or blood) at screening will exclude you.
  • For women who could become pregnant: having unprotected sex with a man who is not sterile (has not had a vasectomy for at least 6 months) within 14 days before dosing will exclude you.
  • Having had episodes of low blood sugar (symptoms such as sweating, fast heartbeat, dizziness, loss of consciousness) confirmed by a glucose meter or blood test in the past year will exclude you.
  • History of any serious acid‑base problems such as lactic acidosis or diabetic ketoacidosis will exclude you.
  • History of high blood pressure (systolic >140 mmHg and diastolic >90 mmHg) or low blood pressure (systolic <90 mmHg and diastolic <60 mmHg) measured while sitting will exclude you.
  • Significant gastrointestinal (stomach), hepatic (liver), renal (kidney) or other diseases that could affect how the drug is absorbed, distributed, metabolized, or excreted will exclude you.
  • Positive test for HIV, hepatitis B or C, or syphilis will exclude you.
  • Any abnormal laboratory results that the doctor judges to be clinically important will exclude you.
  • Important abnormalities on the heart’s electrical tracing (ECG) that could affect safety will exclude you.
  • Any major cardiovascular (heart), respiratory (lung), neurological (nerve), reproductive, musculoskeletal (bone), lymphatic, hematological (blood), diabetes/impaired glucose tolerance, immune, connective‑tissue, or other systemic diseases that the doctor believes could jeopardize safety or influence study results will exclude you.
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Verified sites

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  • Verified

    Terapia S.A.

    RomaniaCluj Napoca, Romania

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Investigated drugs

  • Dapagliflozin tablets

    are the test medication being evaluated in this study. They contain the active ingredient dapagliflozin, which helps the kidneys remove excess sugar from the body through the urine. In the trial, participants take these tablets to see how the drug is absorbed and processed compared with a known reference product.

  • Forxiga tablets

    are the reference medication used for comparison. They also contain dapagliflozin, the same active ingredient as the test tablets. The study gives participants these tablets to determine whether the new test tablets work in the same way and reach similar levels in the bloodstream as the established product.

What is already known about the treatment

  • Dapagliflozin tablets 10 mg

    This oral tablet is taken by mouth and contains 10 mg of dapagliflozin. It is an approved medicine that is widely used and described in many clinical studies for treating type 2 diabetes. The drug lowers blood sugar by blocking a protein in the kidneys that normally re‑absorbs glucose, causing excess sugar to leave the body in urine. It belongs to the class of sodium‑glucose co‑transporter‑2 (SGLT2) inhibitors.

  • Forxiga 10 mg film‑coated tablets

    This film‑coated tablet is also taken orally and provides 10 mg of dapagliflozin. It is a marketed, well‑studied product used to control blood glucose in adults with type 2 diabetes. It works in the same way as other SGLT2 inhibitors, preventing the kidneys from re‑absorbing glucose so that more is expelled in the urine. It is classified as an SGLT2 inhibitor.

Investigated diseases

Diabetes mellitus - Diabetes mellitus is a chronic condition in which the body cannot properly regulate blood sugar levels. It develops when the pancreas produces insufficient insulin or when the body's cells do not respond effectively to insulin. Over time, high blood sugar can lead to gradual damage to blood vessels and nerves. The disease often progresses from mild elevation of glucose to higher levels that require ongoing management. Persistent hyperglycemia may cause complications in the eyes, kidneys, and cardiovascular system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506408-18-00Protocol codeDAPAG-02-23Estimated enrolment48 patientsSponsorSun Pharmaceutical Industries Limited

sourced from the EU Clinical Trials Register and site verification

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