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

NCT01055691 | Completed Phase 1

• 1 other identifier: D1691C00002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

healthy volunteers; bioequivalence; dapagliflozin; metformin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (4)

1

EXPERIMENTAL

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

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

2

EXPERIMENTAL

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

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

3

EXPERIMENTAL

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

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

4

EXPERIMENTAL

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

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

Interventions

Dapagliflozin/Metformin DRUG

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

1; 2

Dapagliflozin DRUG

dapagliflozin tablet 2.5 mg Oral Single dose

1; 2

Metformin DRUG

metformin IR tablet 850 mg Oral Single dose

Also known as: Glucophage

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Research Site

Berlin, Germany

Location

MeSH Terms

Interventions

dapagliflozin; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Georg Golor, M.D.

  Parexel

  PRINCIPAL INVESTIGATOR

• Thomas Koernicke

  Parexel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

DE (1)