A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fed Conditions
Overview
- Phase
- Phase 1
- Intervention
- Dapagliflozin 10 mg tablets
- Conditions
- Healthy Subjects
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 fed conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy, non-smoking, male and female subjects, 18 years of age or older.
- •BMI ≥19 and ≤30 kg/m
- •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.
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.
Arms & Interventions
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.
Intervention: Dapagliflozin 10 mg tablets
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.
Intervention: Farxiga® 10 mg tablets
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adverse Events(up to Day 10 post-administration.)