---
title: A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
nct_id: NCT01508195
overall_status: COMPLETED
phase: PHASE1
sponsor: Janssen Research & Development, LLC
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01508195.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01508195"
ct_last_update_post_date: 2013-01-31
last_seen_at: "2026-05-12T06:26:42.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

**Official Title:** A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 500 mg) in Healthy Fed Subjects

**NCT ID:** [NCT01508195](https://clinicaltrials.gov/study/NCT01508195)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** Janssen Research & Development, LLC
- **Conditions:** Healthy
- **Start Date:** 2012-01
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2013-01-31

## Brief Summary

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

## 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 (to see if blood levels of one drug are equivalent to blood levels of another drug) 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 FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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 ECG deemed to be clinically significant by the Investigator
```

## Arms

- **Treatment Sequence AB** (EXPERIMENTAL) — Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.
- **Treatment Sequence BA** (EXPERIMENTAL) — Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.

## Interventions

- **Canagliflozin tablets** (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 1.
- **Metformin IR tablets** (DRUG) — Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
- **Canagliflozin/metformin IR FDC tablets** (DRUG) — Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
- **Canagliflozin/metformin IR FDC tablets** (DRUG) — Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
- **Canagliflozin tablets** (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 2.
- **Metformin IR tablets** (DRUG) — Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

## Primary Outcomes

- **Canagliflozin plasma concentrations** _(time frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2)_
- **Metformin plasma concentrations** _(time frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2)_

## Secondary Outcomes

- **Changes in clinical laboratory test values** _(time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval))_
- **Changes in vital signs measurements** _(time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval))_
- **Changes in electrocardiogram (ECG) parameters** _(time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval))_
- **Changes in physical examination results** _(time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval))_
- **The number of patients reporting adverse events** _(time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval))_

## Locations (1)

- Lincoln, Nebraska, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|lincoln|nebraska|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01508195*  
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