Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT03771781
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin Tablets — DRUG
    Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
  • Empagliflozin Tab 25 MG — DRUG
    Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.

Study Details

Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.

Key Dates

Start date
Apr 16, 2018
Status verified
Feb 2019
Primary completion
May 25, 2018
Completion
May 25, 2018

Study Design

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

Arms

  • Other: Empagliflozin Tablets
    The test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions.
  • Other: Empagliflozin Tab 25 MG
    The reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions.

Primary Outcome Measure

Peak Plasma Concentration (Cmax) [ Time Frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours ]

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