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

NCT ID: NCT02220218

Last Updated: 2014-11-19

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

2014-10-31

Brief Summary

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The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) 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 tablet 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 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 at pre-dose and post-dose of study treatment, for understanding the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time). Participants' safety will be monitored throughout the study.

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 ABDC

Treatment A (canagliflozin and metformin immediate release \[IR\] fixed dose combination \[FDC\] tablet 50 milligram \[mg\]/500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Intervention Type DRUG

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Canagliflozin

Intervention Type DRUG

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Metformin IR

Intervention Type DRUG

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Treatment Sequence BCAD

Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Intervention Type DRUG

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Canagliflozin

Intervention Type DRUG

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Metformin IR

Intervention Type DRUG

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Treatment Sequence CDBA

Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Intervention Type DRUG

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Canagliflozin

Intervention Type DRUG

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Metformin IR

Intervention Type DRUG

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Treatment Sequence DACB

Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Intervention Type DRUG

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Canagliflozin

Intervention Type DRUG

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Metformin IR

Intervention Type DRUG

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Interventions

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Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Intervention Type DRUG

Canagliflozin

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Intervention Type DRUG

Metformin IR

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Intervention Type DRUG

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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28431754DIA1070

Identifier Type: OTHER

Identifier Source: secondary_id

CR104979

Identifier Type: -

Identifier Source: org_study_id