A Bioequivalence Study of the Fixed Dose Combination Tabl... | NCT02077803

Studies
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

NCT02077803

Sponsor

Janssen Research & Development, LLC

Status

Completed

Last Update Posted

Sep 3, 2014Estimated

Enrollment

47Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Canagliflozin, 100 mg
Metformin XR, 500 mg
CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg
CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
28431754DIA1062	Other Identifier	Janssen Research & Development, LLC

Official Title

A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 28, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.

Detailed Description

This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of Fixed Dose Combination (FDC) tablets of canagliflozin (CANA) and metformin extended release (MET XR) in comparison with tablets of individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets will be of the same strength (50 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 4 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.	Drug: Canagliflozin, 100 mg Drug: Metformin XR, 500 mg
Treatment B	Experimental	Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions.	Drug: CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg
Treatment C	Experimental	Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.	Drug: CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Canagliflozin, 100 mg	Drug	Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of canagliflozin following the single dose of drug administration	Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.	Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4
Plasma concentration of metformin following the single dose of drug administration	Plasma concentrations of metformin are used to evaluate how long it stays in the body.	Day 1 to Day 2 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, and 30 hours postdose); and Day 3 (36 hours)

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability		Up to Day 10 of the follow-up period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must sign an informed consent document indicating they understand the purpose of the study and procedures
Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
Must have a body weight of not less than 50 kg
Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

History of or current clinically significant medical illness
Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
Known allergy to heparin or history of heparin induced thrombocytopenia
Donated blood or blood products or had substantial loss of blood within 3 months before screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tempe	Arizona		United States

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates