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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Dapagliflozin; Drug: Dapagliflozin/Metformin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055691

D1691C00002

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

1

Experimental group

Description:

Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Drug: Dapagliflozin/Metformin

Drug: Dapagliflozin/Metformin

Drug: Metformin

Drug: Dapagliflozin

2

Experimental group

Description:

Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Drug: Dapagliflozin/Metformin

Drug: Dapagliflozin/Metformin

Drug: Metformin

Drug: Dapagliflozin

3

Experimental group

Description:

Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Drug: Dapagliflozin/Metformin

Drug: Dapagliflozin/Metformin

Drug: Metformin

Drug: Dapagliflozin

4

Experimental group

Description:

Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Drug: Dapagliflozin/Metformin

Drug: Dapagliflozin/Metformin

Drug: Metformin

Drug: Dapagliflozin