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

NCT01463774 | Completed Phase 1

• 2 other identifiers: CR10067428431754DIA1039
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin

Outcome Measures

Primary Outcomes (2)

• Canagliflozin plasma concentrations

  Up to 72 hours

• Metformin plasma concentrations

  Up to 72 hours

Secondary Outcomes (3)

• Adverse events

  Up to approxmately 23 days

• Changes from baseline in clinical laboratory test results

  Up to approximately 23 days

• Vital Signs

  Up to approximately 23 days

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

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

Drug: Treatment A: Canagliflozin tablet; Drug: Treatment A: Metformin IR tablets; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets

Treatment Sequence BA

EXPERIMENTAL

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

Drug: Treatment A: Canagliflozin tablet; Drug: Treatment A: Metformin IR tablets; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets

Interventions

Treatment A: Canagliflozin tablet 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 Sequence AB; Treatment Sequence BA

Treatment A: Metformin IR tablets 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 Sequence AB; Treatment Sequence BA

Treatment B: Canagliflozin/metformin fixed dose combination tablets 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 AB; Treatment Sequence BA

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Janssen Research & Development, LLC L.LC. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: November 2, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

US (1)