Comparative bioequivalence study of the miglustat 100-mg Capsules manufactured by Modava Pharmaceutical Company

Not Applicable

Recruiting

• Conditions: -.

• Registration Number: IRCT20130313012810N8
• Lead Sponsor: Modava Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

The weight range of participating candidates should be between 60-100 kg
All candidates must be non-smokers
Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
Volunteers who have agreed to an informed consent form
All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw

Exclusion Criteria

History of allergic or adverse reaction to miglustat or any similar product
Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
smokers
Treatment with enzyme-modifying drugs or taking any drug within 2 weeks before receiving the drug

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of the drug. Timepoint: 14 sampling time till 24 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).