A Phase 1 interventional study of CANA/MET XR FDC in Healthy Volunteers, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-02.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
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.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg
Drug: CANA/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)
Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Time frame: Day 1, Day 7
Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets
Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Time frame: Day 1, Day 7
Percentage of participants with adverse events as a measure of safety and tolerability
Time frame: Screening, up to Day 10 of the follow-up
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC