MedTrace Logo

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components

NCT05266404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-07-05

No results posted yet for this study

Summary

A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject

Conditions

  • Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)

Interventions

DRUG

Dapagliflozin/sitagliptin FDC

Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.

DRUG

Sitagliptin

Subjects will receive 100 mg single dose of Sitagliptin orally.

DRUG

Dapagliflozin

Subjects will receive 10 mg single dose of Dapagliflozin orally.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT05266404 on ClinicalTrials.gov