A Drug-Drug Interaction Study of Losartan and PA21

Vifor

Status and phase: Completed; Phase 1

Conditions: Drug Interaction Potentiation

Treatments: Drug: No PA21; Losartan with food; Drug: PA21 and Losartan with Food; Drug: PA21 with food and Losartan 2 hours later

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324752

PA-DDI-001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Written informed consent

Exclusion criteria

• No significant medical conditions
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

PA21 and Losartan with food

Experimental group

Treatment:

Drug: PA21 and Losartan with Food

No PA21; Losartan with food

Experimental group

Treatment:

Drug: No PA21; Losartan with food

PA21 with food and Losartan 2 hrs later

Experimental group

Treatment:

Drug: PA21 with food and Losartan 2 hours later