A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055691

Enrollment

120

Registered

2010-01-26

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

healthy volunteers, bioequivalence, dapagliflozin, metformin

Brief summary

The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.

Interventions

DRUGDapagliflozin/Metformin

Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose

DRUGDapagliflozin

dapagliflozin tablet 2.5 mg Oral Single dose

DRUGMetformin

metformin IR tablet 850 mg Oral Single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Female healthy volunteers must be post-menopausal (cessation of menses \>1year), be surgically sterile (documented) or hysterectomy or on abstinence * Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values

Exclusion criteria

* Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization * History of allergy to metformin * Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study

Design outcomes

Primary

Measure	Time frame
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.	Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.

Secondary

Measure	Time frame
To examine the safety and tolerability of the combination of dapagliflozin and metformin.	Throughout study (for 4 days in each period and a follow-up visit ~6 days later)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026