Therapeutic Equivalency Healthy volunteer
Conditions
Interventions
A single dose of Baraclude® Tablet 1.0 mg will be administered after an overnight fasting of at least 8 hours. The tablet will given along with 240 mL drinking water. No food will be allowed for 4 ho
Active Comparator Drug,Experimental Drug
Baraclude® Tablet 1.0,Bucretis® Orodispersible Film 1.0 mg
Sponsors
Abbott Healthcare Products B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male/Female must be 18-55 years of age, body mass index (BMI) = 18-25 kg/m2, inclusive. 2. Must be in good health as determined by medical history, vital signs (systolic blood pressure not lower than 90 or not over 140 mmHg, diastolic blood pressure not lower than 60 or not over 90 mmHg), and physical examination 3. Screening electrocardiogram (ECG) without clinically significant abnormalities 4. Screening visit Laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr) analysis and liver function test (aspartate aminotransferase (AST)/ alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT)), total protein, albumin, creatinine phosphokinase (CPK), lactic dehydrogenase (LDH), lactic acid, sodium (Na+), potassium (K+), chloride (Cl-), biocarbonate (CO2) must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator. 5. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator 6. Must have serum HbsAg and anti-hepatitis C antibody (anti-HCV) negative 7. Must have negative result of anti-HIV 8. Female subjects must have serum β-HCG negative. 9. Female subject who is childbearing potential agrees to use an acceptable birth control method from visit 1 to the follow up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD), and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow up visit. Hormonal contraceptives are not acceptable. 10. Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)). 11. Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing. 12. Non-smokers (never smoked or no smoking within the previous 2 years) 13. Refrain from using herbal medications, dietary supplements (e.g., St. John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period II. 14. Subjects must have ended any medications at least 30 days prior to administration of study drug and must not have a depot injection or an implant of any medications within 6 months prior to administration of study drug and agree to continue their refraining throughout the follow up period. 15. Subjects must refrain from drinking caffeine and alcohol for at least 72 hours and one month, respectively prior to administration of study drug on Day 1 and agree to continue their refraining throughout the last collection time-point of period II. 16. Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic C
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to entecavir and any other similar class of drugs and to any of its components 2. Past medical history of, pulmonary, renal, hepatic, pancreas, hematological, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease and asthma 3. Subject has clinically significant disorders or a history of any illness that, in the opinion of the investigator, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history or presence of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness, respiratory system, urological disorder; or history of mental illness that may affect compliance with study requirements. 4. Subjects with stomatitis and glossitis that may affect buccal absorption of investigational drugs 5. Subjects with an unhealed wound after tooth extraction or a wound on the tongue or oral mucosa 6. Subjects who have a significant infection such as influenza at the time of screening and/or admission or known inflammatory process at screening and subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhea, heartburn). 7. Have history of drug abuse in the last 12 months 8. Subjects who tested positive test result for drugs of abuse (opiate (morphine), benzodiazepine, methamphetamines, barbiturate, cannabinoid (tetrahydrocannabinol (THC)), cocaine and 3,4- methylenedioxy- methamphetamine (MDMA)) at screening or admission (the day prior to dosing) 9. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months 10. Subjects who have a positive alcohol breathing test at screening or admission (the day prior to first dosing). 11. Female subject is pregnant or breast feeding. 12. Difficulty in swallowing whole tablets and capsules 13. Difficulty in fasting or consuming standard meals 14. Donation or loss of whole blood: a. ≥ 50 mL and ≤ 499 mL within 30 days prior to dosing b. ≥ 500 mL within 56 days prior to dosing 15. Participation in any investigational drug study within 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence of Bucretis® Orodispersible Film 1.0 mg pre-dose (duplicate), at 10, 20, 30, 40 and 50 minutes after dosing, and at 1, 1.25, 1.5, 1.75, 2, 2 AUC0-t,Bioequivalence of Bucretis® Orodispersible Film 1.0 mg pre-dose (duplicate), at 10, 20, 30, 40 and 50 minutes after dosing, and at 1, 1.25, 1.5, 1.75, 2, 2 Cmax,Bioequivalence of products using PK parameters of Cmax and AUC0-t pre-dose (duplicate), at 10, 20, 30, 40 and 50 minutes after dosing, and at 1, 1.25, 1.5, 1.75, 2, 2 Plasma concentration using LC/MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| - - - | — |
Countries
Thailand
Contacts
Public ContactPearlta Tripuvanuntakul
Sponsor
Outcome results
None listed