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Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects

NCT04877106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-05-07

No results posted yet for this study

Summary

An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition) to assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets.

Conditions

  • Healthy Subjects

Interventions

DRUG

Sitagliptin Phosphate/metformin Hydrochloride Tablets(JANUMET®,50mg/850mg)

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®, 50mg/850mg)

DRUG

Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Doctor Cao · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-07
Primary Completion
2018-05-20
Completion
2018-07-31

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 NCT04877106 on ClinicalTrials.gov