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Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects

NCT05956522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Test Empagliflozin And Linagliptin Tablets

specification: 25 mg/5 mg, manufacturer: Qilu Pharmaceutical (Hainan) Co., Ltd

DRUG

Reference Empagliflozin And Linagliptin tablets

specification: 25 mg/5 mg, manufacturer: Boehringer Ingelheim International GmbH \& Co. KG

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-11-23
Completion
2023-01-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956522 on ClinicalTrials.gov