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NCT01324752 Clinical Trial

A Drug-Drug Interaction Study of Losartan and PA21

Drug Interaction Potentiation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01324752
Other study ID # PA-DDI-001
Secondary ID
Status Completed
Phase Phase 1
First received March 25, 2011
Last updated December 19, 2012
Start date March 2011
Est. completion date June 2011

Study information
Verified date December 2012
Source Vifor Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if Losartan potassium is affected by PA21.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- Written informed consent

Exclusion Criteria:

- No significant medical conditions

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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.
• No PA21; Losartan with food
The maximum dose of Losartan will be 100 mg/day.
• 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.

Locations
Country Name City State
United States ACRI- Phase 1 Anaheim California

Sponsors (1)
Lead Sponsor Collaborator
Vifor Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of PA21 on Losartan potassium To assess the effect, if any, of PA21 on Losartan potassium exposure PK assessment on Day 0, 11, 22 No
Secondary Effect of PA21 on the active metabolite of Losartan potassium To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium PK assessment on Day 0, 11, 22 No
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