TCTR20180202001Not yet recruiting未知
A Single Dose Two-Way Crossover Bioequivalence Study of Desloratadine Tablets (5 mg) in Normal, Healthy, Adult, Human Subjects under Fasting Condition
Sun Pharmaceutical Industries Limited0 sites32 target enrollmentStarted: February 2, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Male/Female must be 18.0-55.0 years of age, body mass index (BMI) =
- •18.0-25.0 kg/m2, inclusive.
- •2. Must be in good health as determined by medical history, vital signs
- •(blood pressure (systolic blood pressure not lower than 90 or not over
- •129 mmHg, diastolic blood pressure not lower than 60 or not over 79
- •mmHg), body temperature, pulse rate, respiratory rate) and physical
- •examination or showing no clinically significant abnormalities in the
- •opinion of clinical investigator
- •3. Screening electrocardiography (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) and liver function
- •test (aspartate aminotransferase (AST)/alanine aminotransferase
- •(ALT), direct bilirubin, total bilirubin, albumin, total protein and
- •alkaline phosphatase (ALP)) 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 hepatitis B surface antigen (HbsAg), hepatitis C virus
- •antibody (anti-HCV), human immunodeficiency virus antibody (anti-
- •HIV) and venereal disease research laboratory test (VDRL)
- •seronegative
- •7. Female subjects must have beta-subunit of human chorionic
- •gonadotropin in serum (β-HCG) negative.
- •8. Female subject who is childbearing potential or male subject 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.
- •9. Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)
- •10. 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 at period I and period II.
- •11. Non-smokers (never smoked or no smoking within the previous 1
- •12. 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.
- •13. Subjects must have ended any medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow up
- •14. Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period II.
- •15. Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an
- •Independent Ethic Committee (IEC)/Institutional Review
Exclusion Criteria
- •1. Known hypersensitivity to desloratadine and its components
- •2. Past medical history of renal and hepatic insufficiency
- •3. Subject has 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 of pulmonary obstructive disease, bronchial asthma,
- •hypertension, glaucoma, cardiovascular, gastrointestinal, central
- •nervous system disease, renal and hepatic impairment; history or
- •presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- •4. Have history of drug abuse in the last 12 months
- •5. Have positive result of urine drug abuse testing on opioids (morphine (Mor), methadone (MTD)), cannabiniods (tetrahydrocannabinol
- •(THC)), methamphetamine (Meth), cocaine (Coc) and methylenedioxy-methamphetamine (MDMA) at screening visit or before dose administration at each period
- •6. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months
- •7. Have positive result of alcohol breathing test at screening visit or before dose administration at each period
- •8. Female subject is pregnant or breast feeding.
- •9. Difficulties fasting or consuming standard meals
- •10. 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.
- •11. Participation in any investigation drug study within 1 month
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