A Drug-Drug Interaction Study of Omeprazole and PA21

Vifor

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PA21 and Omeprazole with food; Drug: No PA21; Omeprazole with food; Drug: PA21 with food, Omeprazole 2hrs later

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452906

PA-DDI-003

Details and patient eligibility

About

The purpose of this study is to determine if Omeprazole 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 Omeprazole with food

Experimental group

Treatment:

Drug: PA21 and Omeprazole with food

No PA21; Omeprazole with food

Experimental group

Treatment:

Drug: No PA21; Omeprazole with food

PA21 with food, Omeprazole 2 hrs later

Experimental group

Treatment:

Drug: PA21 with food, Omeprazole 2hrs later