A Drug-Drug Interaction Study of Furosemide and PA21
This study has been completed.
Sponsor:
Vifor Inc.
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01438359
First received: September 16, 2011
Last updated: September 29, 2011
Last verified: September 2011
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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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: 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:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Furosemide
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers
- Written informed consent
Exclusion Criteria:
- No significant medical conditions
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Vifor Inc. |
| ClinicalTrials.gov Identifier: | NCT01438359 History of Changes |
| Other Study ID Numbers: | PA-DDI-002 |
| Study First Received: | September 16, 2011 |
| Last Updated: | September 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vifor Inc.:
|
Drug-drug interaction Pharmacokinetics PA21 Drug Interaction Potentiation |
Additional relevant MeSH terms:
|
Furosemide Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013