Bioequivalence of Miglustat capsule

Study of bioequivalence of 100mg Miglustat capsule in healthy volunteers after single dose oral administration

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210201050197N7

Enrollment

Registered

2023-12-24

Start date

2024-01-05

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention 1: Intervention group: In this group, 12 volunteers receive a 100 mg Miglustat capsule made by Pharan shimi Company. Up to 24 hours, blood samples will be taken from the volunteers and pl

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer Age_18-50 year

Exclusion criteria

Exclusion criteria: History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration of the drug. Timepoint: Before intervention and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: liquid chromatography-mass (LC-MS) device.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Haeri

Shahid Beheshti University of Medical Sciences

a_haeri@sbmu.ac.ir+98 21 8820 0212

Outcome results