Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: pantoprazole; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206050

D9612L00066

Details and patient eligibility

About

This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent.
• Males and females aged 18 to 70 years, inclusive.
• Male or non-pregnant, nonlactating female healthy volunteer subjects. Females must be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.

Exclusion criteria

• Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
• Previous enrollment or randomization of treatment in the present study.
• Received an experimental drug or used an experimental device within 28 days preceeding the screening visit.