A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of FDC Tablets of Canagliflozin and Metformin IR (2x150 mg/1000 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR (2x1000 mg) Tablets in Healthy Fed Subjects |
- Canagliflozin plasma concentrations [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
- Metformin plasma concentrations [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Up to approxmately 23 days ] [ Designated as safety issue: No ]The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-15 washout period between treatment periods (total time is approximately 23 days).
- Clinical Laboratory Tests [ Time Frame: Up to approximately 23 days ] [ Designated as safety issue: No ]
- Vital Signs [ Time Frame: Up to approximately 23 days ] [ Designated as safety issue: No ]
| Enrollment: | 83 |
| Study Start Date: | September 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment Sequence AB |
Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)
Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
|
| Experimental: Treatment Sequence BA |
Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
|
Detailed Description:
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as a fixed dose combination (FDC) tablet (ie, canagliflozin and metformin IR in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 30 kg/m² 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
Contacts and Locations| United States, Nebraska | |
| Lincoln, Nebraska, United States | |
| Study Director: | Janssen Research & Development, LLC L.LC. Clinical Trial | Janssen Research & Development, LLC |
More Information
No publications provided
| Responsible Party: | DIRECTOR, CLIN PHARM LEADER, Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01463228 History of Changes |
| Other Study ID Numbers: | CR100636, 28431754DIA1038 |
| Study First Received: | October 7, 2011 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Janssen Research & Development, LLC:
|
Healthy Volunteers Bioequivalence Canagliflozin (JNJ-28431754) Metformin IR |
Additional relevant MeSH terms:
|
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013