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Canagliflozin once daily and HCTZ once daily

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 16, 2012

Target and mechanism

ModalitySmall molecule

Also known as Canagliflozin once daily and twice daily

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Canagliflozin once daily and HCTZ once daily · 2 trials · 1 indication

Phase 1 2
NCT01294631A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy VolunteersHealthy
COMPLETED30 Analytics
NCT01286103A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult VolunteersHealthy
COMPLETED34 Analytics
PHASE1COMPLETED
A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Urine glucose concentration
At protocol-specified time points up to Day 36 in Period 2
Plasma concentrations of canagliflozin
Up to Day 5 after the last treatment
Plasma concentrations of glucose
Up to Day 5 after the last treatment
Urinary glucose excretion (UGE)
Up to Day 5 after the last treatment
Renal threshold of glucose (RTG)
Up to Day 5 after the last treatment

Secondary Endpoints

Plasma concentration of canagliflozin
Up to Day 36 in Period 2
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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALCanagliflozin 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..
002EXPERIMENTALCanagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

Interventions

NameTypeDescription
Canagliflozin 300 mg once daily and HCTZ 25 mg once dailyDRUGPeriod 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..
Canagliflozin 300 mg once daily and 150 mg twice dailyDRUGTreatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
Canagliflozin 100 mg once daily and 50 mg twice dailyDRUGTreatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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...

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