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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT00472550
Eligibility Criteria:
Inclusion Criteria:
* Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included.
* Before inclusion blood will be drawn and the following blood count, liver, pancreas, kidney, thyroid and coagulation parameters will be examined:
* Creatinine (0.5 - 1.3 mg/dl),
* Alc. Phosphatase (38 - 126 U/l),
* GGT (0 - 85 U/l),
* ALAT (0 - 50 U/l),
* ASAT (0 - 37 U/l),
* LDH (0 - 248 U/l),
* Cholinesterase (\>7000 U/l),
* Amylase (25 - 130 U/l),
* Lipase (114 - 300 U/l),
* Leucocytes (3,5 - 11.0 10E9/L),
* Erythrocytes (4.0 - 5.9 10E12/L),
* Hb (12.0 - 17.5 g/dl),
* Ht (33 - 50%),
* Platelets (145 - 440 10E9/L),
* CrP (\< 10 mg/l),
* TSH (0.4 - 5.0 mE/l),
* fT4 (6 - 23 pmol/l),
* INR (0.75 - 1.30),
* PTT (15.0 - 33.0 sec.)
The results have to be within the physiological range (as given in parenthesis).
Moreover, volunteers have mentally to be able to understand the explanations concerning the study and follow to the instructions of the investigator.
Exclusion Criteria:
* Any acute or chronic disease,
* Heartburn more than once weekly,
* Alcohol consumption of more than 50 g ethanol-equivalent per week,
* Smoking,
* Known hypersensitivity against esomeprazole,
* Benzimidazole or other ingredients of the medication,
* Fructose-intolerance,
* Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00472550
Study Brief:
Protocol Section:
NCT00472550