- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Urine glucose concentration
Tidsramme: At protocol-specified time points up to Day 36 in Period 2
|
At protocol-specified time points up to Day 36 in Period 2
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Plasma concentration of canagliflozin
Tidsramme: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma concentration of hydrochlorothiazide (HCTZ)
Tidsramme: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma glucose concentration
Tidsramme: 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
Tidsramme: Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
Plasma and urine electrolyte assessment
Tidsramme: Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
The number and type of adverse events reported
Tidsramme: Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR017851
- 28431754DIA1034
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Kliniske forsøg med Canagliflozin 300 mg once daily and HCTZ 25 mg once daily
-
Vanderbilt University Medical CenterAfsluttetGlukosemetabolismeforstyrrelser | Metaboliske sygdomme | Diabetes mellitus | Sygdomme i det endokrine systemForenede Stater