A Drug-Drug Interaction Study of Warfarin and PA21

Vifor

Status and phase: Completed; Phase 1

Conditions: Drug Interaction Potentiation

Treatments: Drug: PA21; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01477424

PA-DDI-005

Details and patient eligibility

About

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

Enrollment: 45 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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45 participants in 3 patient groups

PA21 and Warfarin with food

Experimental group

Description:

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day

Treatment:

Drug: PA21

Drug: Warfarin

No PA21; Warfarin with food

Experimental group

Description:

The maximum dosage of Warfarin will be 10 mg/day

Treatment:

Drug: Warfarin

PA21 with food and Warfarin 2hrs later

Experimental group

Description:

The maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day

Treatment:

Drug: PA21

Drug: Warfarin