Levetiracetam tablet 1000mg (LEVEBEL 1000mg, Cobel Darou) In- Vivo Bioequivalence study in Iranian healthy volunteers

In- Vivo Bioequivalence study of Levetiracetam tablet 1000mg Cobel Darou (LEVEBEL 1000mg) with brand drugs (KEPPRA 1000mg UCB Pharma, Belgium) in Iranian healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N1

Enrollment

Registered

2020-04-12

Start date

2020-02-19

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

in this study the bioequivalence of test and brand of levetiracetam will evaluated..

Interventions

Crossover study with two intervention groups. Intervention group A (Sequence 1, volunteers 1-12) and intervention group B (sequence 2, volunteers 13-24) without control group based on the guidelines o

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver & heart & kidney ) Body mass index (18-25) Informed consent Age (18-60 )

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of Liver & Kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity

Design outcomes

Primary

Measure	Time frame
Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC, LC-MS/MS or UPLC-MS/MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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