Healthy volunteers
Conditions
Interventions
1 Study A
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A 20 mg tablet/capsule of esomeprazole will be taken with 250 ml drinking water at room temperature.
2. Study B
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calorie breakfast will be served 30 minutes before drug administration. Subjects should to take the meal completely within 30 minutes after serving.
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After serving the meal for 30 minutes,
subjects will take a 20 mg tablet/capsule of esomeprazole with 250 ml drinking water at room temperature.
,1 Study A
-
subjects will take a 20 mg tablet/capsule of esomeprazole with 250 ml drinking water at room temperature.
Active Comparator Drug,Active Comparator Drug
STARMECT CAP 20,NEXIUM®
Sponsors
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
Pharmacy Service Center,
Faculty of Pharmacy,
Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1) Healthy Thai male and female subjects based on medical history and physical examination, aged between 18-45 years. 2) Normal or not clinically significant abnormal of clinical 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. 3) Clinical laboratory result of hepatitis B is negative. 4) No clinically significant findings in vital sign measurement. 5) Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight is not less than 45 kg. 6) Females who participate in this study must: 6.1) be nonpregnant female (negative result for pregnancy test). 6.2) be not currently breastfeeding. 6.3) Abstain from either hormonal contraceptive method (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing IUDs, postcoital contraception) and hormone replacement therapy for at least 28 days before admission in period 1. Injectable contraceptives will be discontinued at least 6 months before admission in period 1. Female subjects of non-childbearing potential must meet at least one of the following criteria before admission in period 1 • Post menopausal for at least 1 year or • Surgically sterile (bilateral ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6.4) For childbearing potential: commit to use acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study judged by the clinical investigators, such as condoms, non-hormonal IUD, or willing to remain abstinence (not engage in sexual intercourse) 7) Subjects are able, willing to comply with study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of allergy to esomeprazole or substituted benzimidazoles or related structures. 2) Subjects with currently or history of alcohol addiction or drug abuse. 3) Subjects with currently or evidence of clinically significant of asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, arrhythmia, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication studied or safety of the subjects. 4) Subjects who has history of use of tobacco or nicotine containing products within six months before admission in period 1 and cannot abstain during the study 5) Subjects who use any medications including vitamins, herbal products, and dietary supplement, within 14 days before admission in period 1 and cannot abstain during the study 6) Subjects who are unable to refrain from consumption of orange, pomelo, grapefruit within 7 days before admission in period 1 and cannot abstain during the study 7) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before admission in period 1 and cannot abstain during the study. 8) Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates). 9) Subjects with positive alcohol breath test. 10) Subjects with a history of surgery or blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study. 11) Subjects who participate in other clinical trials within 90 days before the initiation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| esomeprazole concentration in plasma (fasting condition) 0.0 - 12.0 h AUC0-t, AUC0-inf, and Cmax ,esomeprazole concentration in plasma (fed condition) 0.0 - 24.0 h AUC0-t, AUC0-inf, and Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| safety at the beginning and at the end of the trial. clinical and laboratory examinations | — |
Countries
Thailand
Contacts
Public ContactKanokporn Niwatananun
Pharmacy Service Center
Outcome results
None listed