A Drug-Drug Interaction Study of Digoxin and PA21

Vifor

Status and phase: Completed; Phase 1

Conditions: Drug Interaction Potentiation

Treatments: Drug: Digoxin; Drug: PA21

Study type: Interventional

Funder types: Industry

Identifiers

NCT01477411

PA-DDI-004

Details and patient eligibility

About

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

Enrollment: 42 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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42 participants in 3 patient groups

PA21 and Digoxin with food

Experimental group

Description:

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day

Treatment:

Drug: Digoxin

Drug: PA21

No PA21; Digoxin with food

Experimental group

Description:

The maximum dosage of Digoxin will be 0.5 mg/day

Treatment:

Drug: Digoxin

PA21 with food and Digoxin 2hrs later

Experimental group

Description:

The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day

Treatment:

Drug: Digoxin

Drug: PA21