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A Drug-Drug Interaction Study of Furosemide and PA21

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438359
First Posted: September 22, 2011
Last Update Posted: September 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vifor Inc.
  Purpose
The purpose of this study is to determine if Furosemide is affected by PA21.

Condition Intervention Phase
Healthy Drug: PA21 and Furosemide with food Drug: No PA21; Furosemide with food Drug: PA21 with food and Furosemide 2hrs later Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Furosemide in Healthy Male and Female Adults

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Effect of PA21 on Furosemide [ Time Frame: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose ]
    To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).


Estimated Enrollment: 42
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 and Furosemide with food Drug: PA21 and Furosemide with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day
Experimental: No PA21; Furosemide with food Drug: No PA21; Furosemide with food
The maximum dosage of Furosemide will be 40 mg/day
Experimental: PA21 with food and Furosemide 2hrs later Drug: PA21 with food and Furosemide 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
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): NCT01438359


Locations
United States, California
ACRI - Phase 1
Anaheim, California, United States, 92801
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Peter J Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
  More Information

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01438359     History of Changes
Other Study ID Numbers: PA-DDI-002
First Submitted: September 16, 2011
First Posted: September 22, 2011
Last Update Posted: September 30, 2011
Last Verified: September 2011

Keywords provided by Vifor Inc.:
Drug-drug interaction
Pharmacokinetics
PA21
Drug Interaction Potentiation

Additional relevant MeSH terms:
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action