Healthy volunteers Healthy volunteers
Conditions
Interventions
Esomeprazole 20 mg test IMP,Esomeprazole 20 mg reference IMP
Experimental Drug,Active Comparator Drug
Esomeprazole test product,NEXIUM
Sponsors
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Thai male and female subjects, aged between 20-45 years, using the age at the time of informed consent based on their birthday given. 2) Healthy subjects based on their medical history and physical examination and no evidence or current conditions such as asthma, lung disease, seizures, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the studied medication or compromise the safety of the subjects. 3) Normal or not clinically significant abnormal of laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count, and urinalysis. 4) Negative hepatitis B test result. 5) Not clinically significant findings in vital sign measurement. 6) Not clinically significant findings in electrocardiogram (EKG) or other related abnormality 7) Body weight of at least 45 kg with Body Mass Index (BMI) between 18.5-30.0 kg/m2 8) Have a negative pregnancy test result and be nonpregnant (for female subjects) 9) Not currently breastfeeding (for female subjects) 10) Female Subjects without childbearing potential must fulfill at least one of the following criteria before admission in period 1: - Post menopausal for at least 1 year - Surgical sterilization such as bilateral ligation, bilateral oophorectomy or hysterectomy must have been performed for at least 6 months. 11) Demonstrate willingness to comply with all study procedures and adhere to any restrictions outlined in the protocol.
Exclusion criteria
Exclusion criteria: 1) History of allergy to esomeprazole or related structures or any component of the product. 2) History of alcohol addiction or drug abuse. 3) History of tobacco or nicotine containing product use within the six months preceding study drug administration. 4) Use of injectable contraceptive within 6 months before study drug administration. 5) Use of hormonal contraception, or hormone replacement therapy use within 28 days before study drug administration. 6) Unable to stop consuming alcoholic beverages within 14 days prior to drug administration and during the study. 7) Unable to stop taking any medications, including vitamins, minerals (e.g., iron), herbal products (e.g., St. Johns wort), or dietary supplement within 14 days prior to drug administration and during the study. 8) Unable to stop consuming orange, pomelo, grapefruit, or any products containing these fruits within 7 days before study drug administration and during the study. 9) Unable to stop consuming caffeinated beverages and foods, such as tea, coffee, cocoa, cola, chocolate, or energy drinks, within 3 days before study drug administration and during the study. 10) Testing positive for methamphetamine, cannabinoid, or opiates in a urine drug abuse test. 11) Testing positive on alcohol breath test. 12) Undergoing surgery or blood donation exceeding 300 mL or experiencing significant blood loss within 90 days prior to study drug administration. 13) Participation in other clinical trials within 90 days preceding study drug administration. 14) Inability to communicate effectively, including individuals with language difficulties, poor mental development, psychiatric illness, or impaired cerebral function that may hinder their ability to provide written informed consent or cooperate with the clinical team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Esomeprazole 0 - 12 hours AUC0-t, AUC0-inf, and Cmax in fasting condition,Esomeprazole 0 - 24 hours AUC0-t, AUC0-inf, and Cmax in fed condition | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety at the beginning , during and at the end of the trial. Clinical and laboratory examinations | — |
Countries
Thailand
Contacts
Public ContactNarawadee Niamhum
Faculty of Pharmacy, Chiang Mai University
Outcome results
None listed