Bioequivalence Study of 10 mg Ezetimibe Tablet Preparations in Healthy Thai Volunteers

Phase 1

• Conditions: Ezetimibe; Bioequivalence; Bioequivalence study in healthy volunteers

• Registration Number: TCTR20170719004
• Lead Sponsor: Bio-innova and Synchron.Co.,Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Study Completion: 2018-01-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Healthy Thai male/female subjects between the ages of 18 to 55 years.
2.Body mass index between 18.0 to 25.0 kg/m2.
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5.Female subjects abstain from oral contraception for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® must be discontinued at least 6 months. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study.
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence during study period.
7.Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
8.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

Exclusion Criteria

1.History of allergic reaction or hypersensitivity to ezetimibe or related structure or any of the components of the product.
2.History or evidence of clinically significant hepatic, renal, seasonal allergies, endocrine e.g. thyroid or any condition possibly affecting drug bioavailability or had gastrectomy, enterectomy, gastritis, duodenal or gastric ulceration other than appendectomy.
3.History of treatment for severe acute or chronic disease or had an intensity of abnormal laboratory results which could be increased the risks relative to participant in the study or volunteers are inappropriate to attend the study due to obtain investigational products that may affect the interpretation of the results of research, however, these must be under consideration of clinical investigator.
4.Investigation with blood sample shows positive test for HBsAg or HCVAb.
5.History of fever within 1 week prior to admission in each period.
6.History of severe diarrhea or vomiting within 1 week prior to admission in each period.
7.History of abnormal muscle disease, myalgia, rhabdomyolysis, muscle tenderness or myopathy.
8.History of chronic alcohol consumption or drug addict.
9.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test.
10.Abnormal Creatinine phosphokinase, ≥ 3 times of upper normal limit of reference range at screening laboratory test (not because of exercise).
11.12-lead ECG demonstrating QTc >450 msec, a QRSD interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRSD exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRSD values should be used to determine the subject’s eligibility.
12.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
13.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
14.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
15.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (Marijuana (THC), cocaine, opioids, amphetamines or benzodiazepines).
16.Use of prescription or nonprescription drugs within 14 days prior to admission in Period 1 especially any drugs which affect the metabolizing enzyme such as erythromycin, ketoconazole, except acetaminophen (paracetamol) ≤ 1 g/day.
17.Use of herbal medications or supplements especially St. John’s wort (Hypericum perforatum), vitamin or dietary supplements and cannot abstain for at least 14 days prior to admission and continued until last sample collection in each study period.
18.Consume or drink juice of grapefruit or orange or its supplement/ containing products and cannot abstain for at least 14 days prior to admission and continued until last sample collection in each study period.
19.P

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the maximum concentration and the extent of absorption 0,0.25,0.5, 0.75, 1,1.33,1.67, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72hours Pharmacokinetic parameters (Cmax, AUC0-72)

Secondary Outcome Measures

Name	Time	Method
Safety; Adverse events 0, 1.0, 2.0, 3.0, 4.0, 7.0, 10.0, 24.0, 48.0 and 72.0 hours Safety monitoring