Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions

NCT04880993 | Completed Phase 1

• 1 other identifier: 2020-4925
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 0.25, 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

  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

  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 Outcomes (1)

• Adverse Events

  up to Day 10 post-administration.

Study Arms (2)

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.

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.

Drug: Farxiga® 10 mg tablets

Interventions

Dapagliflozin 10 mg tablets DRUG

Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd

Test Product

Farxiga® 10 mg tablets DRUG

Manufactured by AstraZeneca Pharmaceuticals LP

Reference Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

dapagliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: December 14, 2020
• Primary Completion: December 24, 2020
• Study Completion: February 4, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)