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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01294631

Enrollment

Registered

2011-02-11

Start date

2011-03-31

Completion date

2011-07-31

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Canagliflozin, JNJ-28431754, Hydrochlorothiazide, Pharmacokinetic, Pharmacodynamic

Brief summary

The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide and canagliflozin on the concentrations of each drug in the blood and the concentration of glucose in the blood and urine in healthy adult volunteers.

Detailed description

This is a single-center, open-label study with 2 study periods where volunteers and study staff will know the names and doses of assigned study treatments. All volunteers will receive the same treatment. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM), and hydrochlorothiazide (HCTZ) is a drug indicated for the treatment of patients with mild to moderate hypertension. During Period 1, volunteers will take canagliflozin 300 mg once daily for 7 days (Days 1 to 7) and during Period 2, volunteers will take HCTZ 25 mg once daily for 28 days (Days 1 to 28), and then starting on Day 29, will take canagliflozin 300 mg once daily and HCTZ 25 mg once daily for 7 days (Days 29 to 35). Period 1 and Period 2 will be separated by a minimum of 14 days.

Interventions

DRUGCanagliflozin 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..

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Urine glucose concentration	At protocol-specified time points up to Day 36 in Period 2

Secondary

Measure	Time frame
Plasma concentration of hydrochlorothiazide (HCTZ)	Up to Day 36 in Period 2
Plasma glucose concentration	At protocol-specified time points up to Day 36 in Period 2
Plasma concentration of canagliflozin	Up to Day 36 in Period 2
Plasma and urine electrolyte assessment	Up to Day 36 in Period 2
The number and type of adverse events reported	Up to Day 46 in Period 2
Blood pressure and heart rate measurements	Up to Day 46 in Period 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026