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Trial record 63 of 242 for:    furosemide

Drug to Drug Interaction Study With Ipragliflozin and Furosemide

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ClinicalTrials.gov Identifier: NCT01611415
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief Summary:
A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Subjects Pharmacokinetics of Ipragliflozin Drug: Ipragliflozin Drug: Furosemide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Pharmacological Study to Assess Pharmacodynamic and Pharmacokinetic Interactions Between Furosemide and Ipragliflozin in Healthy Subjects
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: ipragliflozin Drug: Ipragliflozin
Oral
Other Name: ASP1941

Experimental: furosemide Drug: Furosemide
Oral

Experimental: ipragliflozin & furosemide Drug: Ipragliflozin
Oral
Other Name: ASP1941

Drug: Furosemide
Oral




Primary Outcome Measures :
  1. Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects [ Time Frame: 6 days ]
  2. Assessment of pharmacodynamic parameters (i.e. calcium, chloride, potassium, phosphate and magnesium in blood and urine) following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects [ Time Frame: 9 days ]
  3. Assessment of the pharmacokinetics of ipragliflozin when co-administered with furosemide compared to ipragliflozin alone [ Time Frame: 10 days ]
    AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)

  4. Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone [ Time Frame: 10 days ]
    AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)

  5. Assessment of the safety and tolerability of furosemide and ipragliflozin following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects [ Time Frame: 39 days ]
    Assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

  • Any of the liver function tests above the upper limit of normal
  • Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
  • A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611415


Locations
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United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Director: Clinical Study Manager Astellas Pharma Europe B.V.

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01611415     History of Changes
Other Study ID Numbers: 1941-CL-0054
2010-024071-98 ( EudraCT Number )
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: May 2012
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Phase 1
Ipragliflozin
Furosemide
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
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Ipragliflozin
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents