Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Canagliflozin, Metformin, INVOKANA®, Type 2 Diabetes Mellitus
Brief summary
The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.
Detailed description
This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.
Interventions
DRUGCANA/MET XR FDC
Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 systemic prescription or nonprescription medication (including vitamins and herbal supplements) * Known allergy to canagliflozin or metformin or any of the excipients of the formulation * Known allergy to heparin or history of heparin induced thrombocytopenia * History of smoking or use of nicotine-containing substances within the previous 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets | Day 1, Day 7 | Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body. |
| Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets | Day 1, Day 7 | Plasma concentrations of metformin are used to evaluate how long it stays in the body. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with adverse events as a measure of safety and tolerability | Screening, up to Day 10 of the follow-up |
Countries
United States
Outcome results
None listed