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A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers

NCT ID: NCT01508182

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

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Detailed Description

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This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Sequence AB

Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods.

Group Type EXPERIMENTAL

Canagliflozin tablets

Intervention Type DRUG

Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.

Metformin IR tablets

Intervention Type DRUG

Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.

Canagliflozin/metformin IR FDC tablets

Intervention Type DRUG

Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.

Treatment Sequence BA

Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between Treatment Periods.

Group Type EXPERIMENTAL

Canagliflozin tablets

Intervention Type DRUG

Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.

Metformin IR tablets

Intervention Type DRUG

Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

Canagliflozin/metformin IR FDC tablets

Intervention Type DRUG

Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.

Interventions

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Canagliflozin tablets

Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.

Intervention Type DRUG

Metformin IR tablets

Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.

Intervention Type DRUG

Canagliflozin/metformin IR FDC tablets

Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.

Intervention Type DRUG

Canagliflozin tablets

Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.

Intervention Type DRUG

Metformin IR tablets

Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

Intervention Type DRUG

Canagliflozin/metformin IR FDC tablets

Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.

Intervention Type DRUG

Other Intervention Names

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Treatment A (Reference) Treatment A (Reference) Treatment B (Test) Treatment A (Reference) Treatment A (Reference) Treatment B (Test)

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria

\- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC L.L.C Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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28431754DIA1050

Identifier Type: OTHER

Identifier Source: secondary_id

CR100679

Identifier Type: -

Identifier Source: org_study_id

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