- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880993
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions
May 6, 2021 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fasting 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 fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
-
Toronto, Ontario, Canada
- Pharma Medica Research Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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.
- 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Product
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.
|
Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd
|
Active Comparator: Reference Product
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.
|
Manufactured by AstraZeneca Pharmaceuticals LP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 hours after drug administration.
|
up to Day 10 post-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 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 hours after drug administration.
|
up to Day 10 post-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 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 hours after drug administration.
|
up to Day 10 post-administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: up to Day 10 post-administration.
|
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.
|
up to Day 10 post-administration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2020
Primary Completion (Actual)
December 24, 2020
Study Completion (Actual)
February 4, 2021
Study Registration Dates
First Submitted
April 30, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 11, 2021
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-4925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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