A Drug-Drug Interaction Study of Losartan and PA21
Sponsor
Vifor Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01324752
Collaborator
(none)
36
1
3
3
11.9
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if Losartan potassium is affected by PA21.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
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 Losartan Potassium in Healthy Male and Female Adults
Study Start Date
:
Mar 1, 2011
Actual Primary Completion Date
:
Jun 1, 2011
Actual Study Completion Date
:
Jun 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PA21 and Losartan with food
|
Drug: PA21 and Losartan with Food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
|
| Experimental: No PA21; Losartan with food
|
Drug: No PA21; Losartan with food
The maximum dose of Losartan will be 100 mg/day.
|
| Experimental: PA21 with food and Losartan 2 hrs later
|
Drug: PA21 with food and Losartan 2 hours later
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
|
Outcome Measures
Primary Outcome Measures
- Effect of PA21 on Losartan potassium [PK assessment on Day 0, 11, 22]
To assess the effect, if any, of PA21 on Losartan potassium exposure
Secondary Outcome Measures
- Effect of PA21 on the active metabolite of Losartan potassium [PK assessment on Day 0, 11, 22]
To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy volunteers
-
Written informed consent
Exclusion Criteria:
-
No significant medical conditions
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ACRI- Phase 1 | Anaheim | California | United States | 92801 |
Sponsors and Collaborators
- Vifor Pharma
Investigators
- Principal Investigator: Peter J Winkle, MD, ACRI - Phase 1 (Advanced Clinical Research Institute)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vifor Pharma
ClinicalTrials.gov Identifier:
NCT01324752
Other Study ID Numbers:
- PA-DDI-001
First Posted:
Mar 29, 2011
Last Update Posted:
Dec 21, 2012
Last Verified:
Dec 1, 2012
Keywords provided by Vifor Pharma
Additional relevant MeSH terms: