Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT04880993
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin 10 mg tablets — DRUG
    Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd
  • Farxiga® 10 mg tablets — DRUG
    Manufactured by AstraZeneca Pharmaceuticals LP

Study Details

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.

Key Dates

Start date
Dec 14, 2020
Status verified
Apr 2021
Primary completion
Dec 24, 2020
Completion
Feb 4, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Cmax [ Time Frame: up to Day 10 post-administration ]

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