MedTrace Logo

Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects

NCT03138356 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-12-07

No results posted yet for this study

Summary

In this integrated, Phase I study, the safety, tolerability, food effect, and pharmacokinetic (PK) properties of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects will be investigated.

Conditions

Interventions

DRUG

2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet

Used in Treatment B and Treatment E.

DRUG

2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet

Used in Treatment A and Treatment D.

DRUG

5 mg dapagliflozin / 850 mg metformin XR FDC

Used in Treatment H.

DRUG

5 mg dapagliflozin / 1000 mg metformin XR FDC

Used in Treatment G.

DRUG

2.5 mg ONGLYZA® (saxagliptin) tablet

Used in treatments C and F.

DRUG

5 mg Forxiga® (dapagliflozin) tablet

Used in treatments C, F and I.

DRUG

500 mg Glucophage XR®

Used in treatments C, F and I.

Sponsors & Collaborators

Principal Investigators

  • Pablo ForteSoto, MD, MSc, PhD · PAREXEL Early Phase Clinical Unit London

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
2017-05-25
Primary Completion
2017-11-28
Completion
2017-11-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT03138356 on ClinicalTrials.gov