Randomized, Single-Dose, Two-Way Crossover, Open-Label Study to Evaluate Pharmacokinetics of Bucretis® Orodispersible Film 1.0 mg and Baraclude® Tablet 1.0 mg in Healthy Thai Subjects under Fasting Conditions
- Conditions
- Therapeutic EquivalencyHealthy volunteer
- Registration Number
- TCTR20161029001
- Lead Sponsor
- Abbott Healthcare Products B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - - -