Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Canagliflozin, Metformin, INVOKANA®, Type 2 diabetes mellitus
Brief summary
The purpose of this study is to assess the effect of coadministration of a high-fat meal on the oral bioavailability of a fixed dose combination of Canagliflozin/extended release Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in healthy participants.
Detailed description
This is a randomized (a sequence of fasted and fed periods accompanying study drug intake will be assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to ensure that at least 20 complete the study. After a screening period, participants will be randomly assigned to 1 of the 2 treatment sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means that a participant will receive the same drug under fed conditions. Participants will need to remain at the study center for 4 days (72 hours postdose) after the drug administration for collection of blood samples in each treatment period. There will be a 10- to 14-day washout period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when participants are discharged from the study center, they will be given instructions to return for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will be provided with a standardized high-fat breakfast. Participants' safety will be monitored throughout the study.
Interventions
DRUGCANA/MET XR FDC
Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 prescription or nonprescription medication (including vitamins and herbal supplements) * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- 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 single dose of CANA/MET XR FDC after fed and fasted conditions | Predose, (before tablet intake) up to 72 hours afterdose | Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body. |
| Plasma concentration of metformin following the single dose of CANA/MET XR FDC after fed and fasted conditions | Predose, up to 72 hours afterdose | Plasma concentrations of metformin are used to evaluate how long metformin 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 period |
Countries
United States
Outcome results
None listed