Healthy SubjectsPhase 1NCT04881006
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions
A Phase 1 study testing Dapagliflozin 10 mg tablets and Farxiga® 10 mg tablets in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the bioequivalence between: Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Dapagliflozin 10 mg tablets and Farxiga® 10 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2020to 15 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥19 and ≤30 kg/m2.
- Females may be of childbearing or non-childbearing potential:
- Childbearing potential:
- o Physically capable of becoming pregnant
- Non-childbearing potential:
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- Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
- Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
- Willing to use acceptable, effective methods of contraception.
- Able to tolerate venipuncture.
- Be informed of the nature of the study and give written consent prior to any study procedure.
Who cannot join
- Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- Known history or presence of hypersensitivity or idiosyncratic reaction to dapagliflozin or any other drug substances with similar activity.
- Known history or presence of congestive heart failure, volume depletion, hypotension, and/or electrolyte imbalances.
- Known history or presence of pancreatitis, DM, lactic acidosis, or acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Known history or presence of clinically significant angioedema.
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- Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
- Presence of hepatic or renal dysfunction.
- History of malabsorption within the last year or presence of clinically significant gastrointestinal disease.
- Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- Known history or presence of genital mycotic infections.
- History or presence of Fournier's gangrene (necrotising fasciitis of the perineum).
- History of drug or alcohol addiction requiring treatment.
- Presence of urinary tract infection, urosepsis, or pyelonephritis.
- Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
- Difficulty fasting or consuming high-fat or standard meals.
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- Females who:
- Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to drug administration;
- Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration;
- Are pregnant (serum hCG consistent with pregnancy); or
- Are lactating.
- Donation or loss of whole blood (including clinical trials):
- ≥50 mL and <500 mL within 30 days prior to drug administration;
- ≥500 mL within 56 days prior to drug administration.
- Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
- On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
- Have had a tattoo or body piercing within 30 days prior to drug administration.
- Have clinically significant findings in vital signs measurements.
- Have clinically significant findings in a 12-lead ECG.
- Have clinically significant abnormal laboratory values.
- Have significant diseases.
- Have clinically significant findings from a physical examination.
- Use of any of the following within 30 days prior to drug administration:
- Drugs that alter gastrointestinal pH/movement (e.g., omeprazole, ranitidine);
- Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism;
- Diuretics (e.g., thiazide and loop diuretics);
- Insulin and insulin secretagogues (e.g., sulphonyl ureas);
- Mefenamic acid;
- Pioglitazone;
- Rifampin;
- Simvastatin; or
- Valsartan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fed Conditions
The primary objective of this study is to evaluate the bioequivalence between:
- Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and
- Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fed conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.
- Conditions
- Healthy Subjects
- Being tested
- Dapagliflozin 10 mg tablets, Farxiga® 10 mg tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mg tabletsDrug
Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Farxiga® 10 mg tabletsDrug
Manufactured by AstraZeneca Pharmaceuticals LP
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Drug: Dapagliflozin 10 mg tablets A single 10 mg dose (1 tablet) of the assigned drug product will be administered according to the randomization scheme with 240±5 mL of room temperature potable water. Receives: Drug: Dapagliflozin 10 mg tablets |
| Reference Product | Active comparator | Manufactured by AstraZeneca Pharmaceuticals LP Drug: Farxiga® 10 mg tablets A single 10 mg dose (1 tablet) of the assigned drug product will be administered according to the randomization scheme with 240±5 mL of room temperature potable water. Receives: Drug: Farxiga® 10 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration (Cmax) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
Measured: up to Day 10 post-administration
AUCt
The area under the plasma concentration-time curve from zero to last measurable concentration (AUCt) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
Measured: up to Day 10 post-administration
AUCinf
The area under the plasma concentration-time curve from zero to infinity (AUCinf) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
Measured: up to Day 10 post-administration
Secondary outcomes (1)
Adverse Events
AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with the treatment. All AEs are classified according to version 23.1 of MedDRA and reported with respect to incidence, frequency, severity, duration, relationship to the investigational medicinal product, action taken, and outcome.
Measured: up to Day 10 post-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start10 Dec 2020
- Primary completion20 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881006
- Sponsor's protocol ID
- 2020-4926
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2021
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fed Conditions
- ClinicalTrials.gov ID
- NCT04881006
- Acronym / sponsor ID
- 2020-4926
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 11 May 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.
The primary objective of this study is to evaluate the bioequivalence between:
- Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and
- Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fed conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Dapagliflozin 10 mg tabletsManufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Drug: Dapagliflozin 10 mg tablets A single 10 mg dose (1 tablet) of the assigned drug product will be administered according to the randomization scheme with 240±5 mL of room temperature potable water. |
| Reference Product | Active comparator | Drug: Farxiga® 10 mg tabletsManufactured by AstraZeneca Pharmaceuticals LP Drug: Farxiga® 10 mg tablets A single 10 mg dose (1 tablet) of the assigned drug product will be administered according to the randomization scheme with 240±5 mL of room temperature potable water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥19 and ≤30 kg/m2.
- Females may be of childbearing or non-childbearing potential:
- o Physically capable of becoming pregnant
- Willing to use acceptable, effective methods of contraception.
Key exclusion criteria (44 listed)
- Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- Known history or presence of hypersensitivity or idiosyncratic reaction to dapagliflozin or any other drug substances with similar activity.
- Known history or presence of congestive heart failure, volume depletion, hypotension, and/or electrolyte imbalances.
- Known history or presence of pancreatitis, DM, lactic acidosis, or acute or chronic metabolic acidosis, including diabetic ketoacidosis.
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 10 mg tabletsManufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | Drug | Test Product |
| Farxiga® 10 mg tabletsManufactured by AstraZeneca Pharmaceuticals LP | Drug | Reference Product |
Primary outcome
Cmax
Time frame: up to Day 10 post-administration
Peak plasma concentration (Cmax) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
AUCt
Time frame: up to Day 10 post-administration
The area under the plasma concentration-time curve from zero to last measurable concentration (AUCt) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
AUCinf
Time frame: up to Day 10 post-administration
The area under the plasma concentration-time curve from zero to infinity (AUCinf) of Dapagliflozin in plasma after administration of the test and the reference products. In Period 1 and Period 2, blood samples were collected at prior to dosing (0-hour) and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration.
1 secondary outcome
Adverse Events
Time frame: up to Day 10 post-administration.
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 11 May 2021.
- Individual participant dataSharing planned: No
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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.
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?
A Phase 1 study testing Dapagliflozin 10 mg tablets and Farxiga® 10 mg tablets in people with Healthy Subjects, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in Canada.
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 11 inclusion and 44 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 11 May 2021. 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 Canada. 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?
Cmax (time frame: up to Day 10 post-administration). 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?
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 11 May 2021.