NCT02851095

Brief Summary

The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets co-administered with canagliflozin in healthy fed and fasted participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

July 28, 2016

Last Update Submit

January 31, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Plasma Concentration (Cmax) of Metformin

    The Cmax is the maximum observed plasma concentration of metformin.

    Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2

  • Area Under the Plasma Concentration Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin

    The AUClast is the area under the plasma concentration time curve from time 0 to the time of the last observed quantifiable concentration (Clast).

    Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2

  • Area Under the Plasma Concentration Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin

    The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

    Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2

Secondary Outcomes (1)

  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Day -1 to End of study (up to 58 Days)

Study Arms (4)

Treatment Sequence ADBC

EXPERIMENTAL

Participants will receive Treatment A (1 canagliflozin tablet 50 milligram (mg) along with two Extended Release (XR) tablet of metformin of each 500 mg orally under fed condition) on Day 1 of treatment period 1, then Treatment D of (1 XR fixed dose combination \[FDC\] tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fasted condition) on Day 1 of treatment period 2, then Treatment B (1 XR FDC tablet containing canagliflozin 50 mg and 1 metformin 1000 mg orally under fed condition) on Day 1 of treatment period 3, followed by Treatment C (1 canagliflozin tablet 50 mg along with 2 metformin (XR) tablets of each 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.

Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin Extended Release (XR)

Treatment Sequence BACD

EXPERIMENTAL

Participants will receive Treatment B on Day 1 of treatment period 1, then Treatment A on Day 1 of treatment period 2, then Treatment C on Day 1 of treatment period 3, followed by Treatment D on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin Extended Release (XR)

Treatment Sequence CBDA

EXPERIMENTAL

Participants will receive Treatment C Day 1 of treatment period 1, then Treatment B on Day 1 of treatment period 2, then Treatment D on Day 1 of treatment period 3, followed by Treatment A on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin Extended Release (XR)

Treatment Sequence DCAB

EXPERIMENTAL

Participants will receive Treatment D on Day 1 of treatment period 1, then Treatment C on Day 1 of treatment period 2, then Treatment A on Day 1 of treatment period 3, followed by Treatment B on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin Extended Release (XR)

Interventions

Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]DRUG

Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.

Treatment Sequence ADBCTreatment Sequence BACDTreatment Sequence CBDATreatment Sequence DCAB
CanagliflozinDRUG

Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.

Treatment Sequence ADBCTreatment Sequence BACDTreatment Sequence CBDATreatment Sequence DCAB
Metformin Extended Release (XR)DRUG

Participants will receive 2 metformin XR tablets of each 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.

Treatment Sequence ADBCTreatment Sequence BACDTreatment Sequence CBDATreatment Sequence DCAB

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
  • Before randomization, a woman must be either Not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception (failure rate of less than \[\<\]1 percent \[%\] per year when used consistently and correctly) throughout the study
  • All women must have a negative urine pregnancy test at Screening and on Day -1 of each Treatment Period
  • Body mass index (BMI) (weight \[kg\]/height\^2 \[m\]2) between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kilogram (kg)
  • Blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, systolic and no higher than 90 mmHg diastolic at Screening or Day -1 of each Treatment Period
  • Normal renal function evidenced by estimated Glomerular Filtration Rate (eGFR) greater than or equal to (\>=90) milliliters per minute (mL/min)/1.73m\^2 using the Modification of Diet in Renal Disease Study (MDRD) equation as defined in the protocol

You may not qualify if:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis as assessed by the investigator at Screening or Day -1 of the first Treatment Period
  • Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) (Screening only) as assessed by the investigator at Screening or on Day -1 of the first Treatment Period as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, hormonal contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

US(1)