Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT01179659
Eligibility Criteria:
Inclusion Criteria:
* Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
* Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
* Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
* Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:
1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
2. Intrauterine device (IUD) in place for at least 3 months.
3. Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
4. Surgical sterilization of the partner (vasectomy for 6 months minimum).
5. Hormonal contraceptives for at least 3 months prior to the first dose of the study.
* Gave voluntary written informed consent to participate in the study.
Exclusion Criteria:
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:
1. Alcoholism or drug abuse within the past 2 years;
2. Hypersensitivity or idiosyncratic reaction to pantoprazole, omeprazole, or any other substituted benzimidazole proton-pump. inhibitors.
* Females who were pregnant or lactating.
* History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
* Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
* Treatment with any known enzyme-altering drugs (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to the first dose.
* Difficulty in swallowing medication or any gastrointestinal disease that would affect the drug absorption.
* Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of:
* 500 mL of blood in 14 days;
* 1500 mL of blood in 180 days;
* 2500 mL of blood in one years.
* Subjects who participated in another clinical trial with 28 days prior to the first dose.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01179659
Study Brief:
Protocol Section:
NCT01179659