Bioequivalence Study of Generic Simvastatin/ Ezetimibe 20/10 mg Tablet
- Conditions
- Healthy subjectsbioequivalence studygenericSimvastatin/ Ezetimibe 20/10 mg Tablet
- Registration Number
- TCTR20230620003
- Lead Sponsor
- Duopharma Biotech Berhad
- Brief Summary
The 90% confidence interval of Cmax and AUC0-t for Ezetimibe, Total Ezetimibe and Simvastatin were within the acceptable limit. The test product is bioequivalent to the reference product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
1. Normal healthy human between 18-45 years (both ages inclusive) of age
2. Volunteer provided written inform consent and are willing to participate in the study
3. Volunteer having body mass index of 18.50-30.00 kg/m3 (both inclusive)
4. No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study
5. Pre-study screening laboratory test are either normal or within acceptable limit or are considered by the investigator to be no clinical significance with respect to participation in the study.
6. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C, and RPR.
7. Non-smoker, non-tobacco (ina any form) users, non alcoholic with negative test for alcohol (in breath), negative urine drug of abuse test
8. 12 lead ECG recording either normal or within acceptable limits or as considered by investigator to be non clinical significance with respect to his/ her participation in the study
9. Normal or clinically non-significant chest x-ray (PA) taken within 06 months before the day of dosing
10. Available for the entire study period and capable of understanding instructions and communicating with the investigators and clinical study facility staff.
11. Female volunteers who have negative result in urine pregnancy test during screening and Beta hCG-test at the time of check-in
12. Female with child bearing potential must agree to use an acceptable method of contraception at least 02 days prior to dosing of IP, during the study and for 14 days following their last dose of IP
13. Male volunteers and/ or female volunteer's partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study
1. Known allergy to Simvastatin and Ezetimibe or any component of the formulation and to any other related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease
3. Female volunteers who are nursing mothers/ lactating women or are found positive in beta hCG test
4. History/ presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year, current alcohol abuse (.5 units/ week, 1 unit= 10 mL or 8 g of pure alcohol) or suspected abuse
5. History of alcohol or drug abuse
6. History of smoking even single cigarette, bidis or any other form
7. History/ presence of asthma
8. History/ presence of urticaria or other allergic-type reactions after taking any medication
9. History/ presence of clinically significant illness within 04 weeks before the start of study
10. History/presence of significant hypersensitivity to heparin
11. History of clinically relevant allergy (except for untreated asymptomatic, seasonal allergies at the time of dosing) or any allergy reaction to any drugs
12. Who is schedule for surgery any time during study or within 14 days after study completion
13. History of difficulty in donating blood
14. Who has unstable veins for repeated venipuncture
15. Who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 ml of blood in last 90 days
16. Who has taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP in Period 1, including topical medication.
17. Who was hospitalized within 28 days prior to administration of the study medication
18. History of difficulty in swallowing
19. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial
20. Who has systolic blood pressure less than 90 mm of the Hg or more than 140 mm of Hg. Minor deviations (2-4 mm Hg) at check in may be acceptable at the discretion of the investigator
21. Who has diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 m m of Hg) at check-in may be acceptable at the discretion of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic pre-dose, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 14.00, 24.00, 48.00 and 72.00 The area under curve (AUC) and Maximum concentration (Cmax) will be calculated
- Secondary Outcome Measures
Name Time Method Safety pre-dose, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 14.00, 24.00, 48.00 and 72.00 To monitor the safety of the subjects and tolerability of single dose formulation