A Drug-Drug Interaction Study of Omeprazole and PA21

A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01452906

Enrollment

Registered

2011-10-17

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2011-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation

Brief summary

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

Interventions

DRUGPA21 and Omeprazole with food

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day

DRUGNo PA21; Omeprazole with food

The maximum dosage of Omeprazole will be 40 mg/day

DRUGPA21 with food, Omeprazole 2hrs later

The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Volunteers * Written informed consent

Exclusion criteria

* No significant medical conditions * Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve from time zero to 24 hours (AUC0-24)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole dose on Days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Area Under the Curve from time zero to infinite (AUC0-infinity)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Maximum observed plasma concentration (Cmax)	pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026