- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294631
A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers
An Open-Label, Two-Period, Fixed-Sequence Study to Explore the Effects of Multiple Doses of Hydrochlorothiazide on the Pharmacodynamics, Pharmacokinetics, and Safety of Multiple Doses of Canagliflozin in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
Exclusion Criteria:
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
Canagliflozin 300 mg once daily and HCTZ 25 mg once daily Period 1: canagliflozin tablets oral 300 mg once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets oral 25 mg once daily for Days 1 to 28 followed by canagliflozin tablets oral 300 mg once daily taken with HCTZ tablets oral 25 mg once daily on Days 29 to 35.. |
Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35.. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine glucose concentration
Time Frame: At protocol-specified time points up to Day 36 in Period 2
|
At protocol-specified time points up to Day 36 in Period 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of canagliflozin
Time Frame: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma concentration of hydrochlorothiazide (HCTZ)
Time Frame: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma glucose concentration
Time Frame: At protocol-specified time points up to Day 36 in Period 2
|
At protocol-specified time points up to Day 36 in Period 2
|
Blood pressure and heart rate measurements
Time Frame: Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
Plasma and urine electrolyte assessment
Time Frame: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
The number and type of adverse events reported
Time Frame: Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR017851
- 28431754DIA1034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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