bioequivalence study of Gabapentine 300 mg capsule in comparison to innovator product

Fasted-state in vivo bioequivalence study of Gabapentine 300 mg capsule manufactured by Fatak shimi Co. in comparison to innovator product Cyklokapron®

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N3

Enrollment

Registered

2021-10-17

Start date

2021-11-01

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

In the present study, no diseases will be examined and products will be administered by healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive one test drug capsule. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administratio

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart and Kidney), Age (20-60)

Exclusion criteria

Exclusion criteria: Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma Drug Concentration. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: Using high performance liquid chromatography (HPLC).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026