Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.

NCT01597700 | Completed Phase 1

• 1 other identifier: 116051
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and given their informed consent will be entered into the study. They will be fasted and receive one tablet by mouth in accordance with a randomisation list and blood samples will be taken at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will receive the opposite tablet and the clinical process repeated. Subjects will be continuously monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events. Drug concentrations will be analysed and these results compared to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported.

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in plasma ezetimibe concentrations in time after dosing

  Liquid chromatography and mass spectrometry

  At 0 time and up to 72 hours after last dose

• Number of participants with adverse events

  Safety monitoring

  At 0 time and up to 72 hours after last dose

• Number of participants with changes in haematology and/or chemistry

  21 to 0 days before first dose and 3 days after last dose

Study Arms (2)

Acotral® ezetimibe 10mg

EXPERIMENTAL

Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 day.

Drug: 10mg Ezetimibe

Zetia® ezetimibe 10mg

ACTIVE COMPARATOR

Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days.

Drug: 10 mg Ezetimibe - wash out period

Interventions

10mg Ezetimibe DRUG

1 tablet taken by mouth

Acotral® ezetimibe 10mg

10 mg Ezetimibe - wash out period DRUG

1 tablet taken by mouth received after wash out period

Zetia® ezetimibe 10mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Literate healthy adult male human subjects within the age range of 18 to 45 years inclusive.
• Weight not less than 50 kg.
• Normal BMI \[18.5 to 24.99 kg/m2 inclusive\].
• Willingness to provide written informed consent to participate in the study and capable of giving written informed consent to participate in the study.
• Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray \[PA view\].
• AST, ALT, alkaline phosphatase and bilirubin 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
• ECG normal for morphology and measurements. QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

You may not qualify if:

• History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.
• History or presence of significant:
• Alcohol dependence, alcohol abuse during past one year.
• Drug abuse for the last one month and other illicit drugs for the last 6 months.
• Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.
• Asthma, urticaria or other allergic type reactions after taking aspirin or any other drug.
• Ulceration or history of gastric and / or duodenal ulcer.
• Jaundice in the past 6 months.
• Bleeding disorder.
• Allergy to the test drug or any drug chemically similar to the drug or to the excipients of the products under investigation.
• Donation of 500 mL blood within 08 weeks prior to receiving the first dose of study drug.
• Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study assessments or compromise subject safety.
• Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
• Refuse to abstain from food for at least 10 h prior to drug administration and for at least 4 h after dose in each period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Electronics City, Bengalore, 560100, India

Location

Related Links

• Results for study 116051 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: May 14, 2012
• Study Start: January 13, 2012
• Primary Completion: January 30, 2012
• Study Completion: January 30, 2012
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

IN (1)