A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Esomeprazole 40 mg DR tablets relative to Nexium® 40 mg tablets in healthy Thai adult volunteers under fasting conditio
- Conditions
- Bioequivalence studyEsomeprazole
- Registration Number
- TCTR20200629001
- Lead Sponsor
- Bio-innova and Synchron.Co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 48
Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
1.Age:18 †55 years, Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.
2.Sex:Males and/or non-pregnant, non-lactating females.
a.Women of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test performed on screening day and prior to the initial dose of each period of study medication.
b.Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
(1) postmenopausal with spontaneous amenorrhea for at least one (1) year
(2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
(3) total hysterectomy and an absence of bleeding for at least 3 months.
3.Weight:Each subject is required to have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2. All weight values are to be reported according to the scale’s precision (i.e. the nearest tenth, 72.3 kg). The subject’s height is to be reported in centimeters to the nearest tenth. Each subject’s BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is to be reported to the nearest tenth (26.3 kg/m2).
4.Smoking Status: Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix VII: Nicotine Equivalence Estimates) are permitted.
•Documentation of smoking status is to be via the questionnaire in Appendix VI, with results included in the study database (if applicable), and Subject’s CRF.
5.Adequate venous access in both arms for the collection of a number of blood samples during the study.
6.Able to understand and sign the written Informed Consent Form.
a.Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidances for the region of submission and country of conductance.
7.Willing to follow the protocol requirements and comply with protocol restrictions and allow investigators to draw approximately 7 mL of blood for monitoring subjects’ safety after the completion of the study.
8.All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include:
a.a normal or non-clinically significant physical examination, including vital signs (blood pressure, pulse rate, respiratory rate and forehead-surface temperature)
b.within normal limits or non-clinically significant laboratory evaluation results for the following tests (unless otherwise noted in the Exclusion Criteria):
•Serum Chemistries
Alkaline PhosphataseAlbuminCreatinineAST
Sugar (glucose)
in fasting bloodTotal ProteinTotal BilirubinALT
Direct BilirubinBUN
•Hematology
Platelet CountWhite Blood Cell CountHemoglobin
HematocritRed Blood Cell CountNeutrophils
LymphocytesMonocytesEosinophils
BasophilsMCV, MCH, MCHC
•Additional tests may be performed, if necessary, based on standard lab panels utilized by the clinical site.
c.Normal
Subject candidates must not be enrolled in the study if they meet any of the following criteria:
1.Institutionalized subjects.
2.Social Habits:
a.Consumption of any alcoholic beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
b.Consumption of any caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
c.Consumption of any vitamins or herbal products within 7 days prior to the initial administration of the study medication and until the completion of the study.
d.Consumption of pomegranate, seville oranges grapefruit, grapefruit-like, or grapefruit containing products within 7 days prior to the initial administration of the study medication and until the completion of the study.
e.Any recent, significant change in dietary or exercise habits.
f.History of drug and/or alcohol abuse within one year of start of study.
g.Use of any nicotine containing product within the 7days prior to the initial administration of study medication until the completion of the study.
3.Medications
a.Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication.
b.A depot injection or implant of any drug within 3 months prior to initial administration of study medication.
c.Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial administration of study medication.
4.Use of any food (e.g. pomegranate, seville oranges grapefruit, grapefruit-like, or grapefruit containing products) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings (e.g. one standard serving of vegetables/fruits is approximately 1 cup) per week within 4 weeks prior to the initial dose of study medication. These foods must be discontinued at least 7 days prior to the initial dose of study medication, during the study and until the end of the study.
5.Diseases:
a.History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
b.History of tuberculosis.
c.History of difficulties in swallowing, or any gastrointestinal disease (i.e. cholecystectomy) or previous GI surgery other than appendectomy which could affect drug absorption. History of gastrointestinal obstruction, particularly paralytic ileus.
d.Acute illness at the time of either the pre-study medical evaluation or dosing period I.
6.Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
7.Intolerance to venipuncture.
8.Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
9.Allergy or hypersensitivity to Esomeprazole, other related products&
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-t and AUC0-inf 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 16, 24 h Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety; Adverse events 0, 1.0, 2.0, 3.0, 4.0, 12.0 and 24.0 h Safety monitoring, vital sign