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Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

NCT ID: NCT02221180

Last Updated: 2014-11-25

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

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.

Detailed Description

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This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each \[Day -1 to Day 2\], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All the eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will be collected for evaluation of pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.

Conditions

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Bioequivalence

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 DACB

Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]

Intervention Type DRUG

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Canagliflozin

Intervention Type DRUG

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Metformin

Intervention Type DRUG

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Treatment Sequence ABDC

Treatment A (1 immediate release (IR) fixed dose combination \[FDC\] tablet containing canagliflozin 150 milligram \[mg\] and metformin 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]

Intervention Type DRUG

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Canagliflozin

Intervention Type DRUG

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Metformin

Intervention Type DRUG

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Treatment Sequence BCAD

Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]

Intervention Type DRUG

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Canagliflozin

Intervention Type DRUG

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Metformin

Intervention Type DRUG

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Treatment Sequence CDBA

Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type EXPERIMENTAL

Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]

Intervention Type DRUG

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Canagliflozin

Intervention Type DRUG

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Metformin

Intervention Type DRUG

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Interventions

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Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Intervention Type DRUG

Canagliflozin

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Intervention Type DRUG

Metformin

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Intervention Type DRUG

Other Intervention Names

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CANA/MET IR FDC CANA MET

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m\^2) (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 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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28431754DIA1071

Identifier Type: OTHER

Identifier Source: secondary_id

CR104980

Identifier Type: -

Identifier Source: org_study_id