Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT05956522
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

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

Interventions

Study Details

To investigate the pharmacokinetics of the test and the reference preparation Empagliflozin And Linagliptin Tablets in healthy adult subjects by single oral administration in fasting/postprandial state, and to evaluate the bioequivalence of the two oral preparations in fasting/postprandial state.

Key Dates

Start date
Jul 1, 2022
Status verified
Jul 2023
Primary completion
Nov 23, 2022
Completion
Jan 13, 2023

Study Design

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

Arms

  • Experimental: Test/reference
    Subjects first receive a single-dose of 25 mg/5 mg test Empagliflozin And Linagliptin tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd ) in the first treatment period and to receive the reference (R, Boehringer Ingelheim International GmbH \& Co. KG )in the second treatment period.
  • Experimental: Reference/test
    Subjects first receive a single-dose of 25 mg/5 mg reference Empagliflozin And Linagliptin tablet (R, Boehringer Ingelheim International GmbH \& Co. KG) in the first treatment period and to receive test tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd) in the second treatment period.

Primary Outcome Measure

Peak Plasma Concentration (Cmax) [ Time Frame: 72hours ]

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