In vivo bioequivalence study of carbamazepine 400 mg sustained-release tablets

The in vivo bioequivalence study of carbamazepine 400 mg sustained release oral tablet manufactured by Sobhan Pharmaceutical Company and Tegretol 400 tablet manufactured by Novartis company

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240819062802N2

Enrollment

Registered

2024-10-29

Start date

2024-10-06

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

A crossover bioequivalence study in 24 healthy volunteers.

Interventions

Intervention 1: Intervention group 1: Twelve healthy volunteers will undergo two phases of a study involving the oral administration of carbamazepine 400 mg tablets. In the first phase, volunteers wil

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers In the age range of 18 to 60 years With a body mass index between 18 and 27 kg per square meter of the body Volunteers who are willing to comply with the requirements of the protocol and provide written informed consent. Non-smokers or smokers who do not smoke during the study.

Exclusion criteria

Exclusion criteria: History of heart, kidney, and liver diseases, pregnancy, Substance abuse Smokers

Design outcomes

Primary

Measure	Time frame
Blood concentration of carbamazepine. Timepoint: 0,1,2,3,4,6,8,10,12,14,16,18,20,22,24,48,72. Method of measurement: Liquid Chromatography Tandem Mass Spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactD?r Somaieh Soltani

Tabriz University of Medical Sciences

somaieh.s@gmail.com+98 41 3337 2250

Outcome results

None listed

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