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A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

NCT ID: NCT01463774

Last Updated: 2012-11-21

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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

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 of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Conditions

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Healthy

Keywords

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Healthy Volunteers Bioequivalence Canagliflozin (JNJ-28431754) Metformin

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

The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.

Group Type EXPERIMENTAL

Treatment A: Canagliflozin tablet

Intervention Type DRUG

Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.

Treatment A: Metformin IR tablets

Intervention Type DRUG

Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.

Treatment B: Canagliflozin/metformin fixed dose combination tablets

Intervention Type DRUG

Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.

Treatment Sequence BA

The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.

Group Type EXPERIMENTAL

Treatment A: Canagliflozin tablet

Intervention Type DRUG

Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.

Treatment A: Metformin IR tablets

Intervention Type DRUG

Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.

Treatment B: Canagliflozin/metformin fixed dose combination tablets

Intervention Type DRUG

Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.

Interventions

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Treatment A: Canagliflozin tablet

Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.

Intervention Type DRUG

Treatment A: Metformin IR tablets

Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.

Intervention Type DRUG

Treatment B: Canagliflozin/metformin fixed dose combination tablets

Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.

Intervention Type DRUG

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

19 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.LC. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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28431754DIA1039

Identifier Type: OTHER

Identifier Source: secondary_id

CR100674

Identifier Type: -

Identifier Source: org_study_id