In-vivo Bioequivalence Study of Lithium carbonate 300 mg Tablets of The Test Drug manufactured by Mofid Pharmaceutical Company

In-vivo Bioequivalence Study of Lithium carbonate 300 mg Tablets of The Test Drug manufactured by Mofid Pharmaceutical Company in Compared with The Reference Drug manufactured by HIKMA Pharmaceuticals made in USA in Iranian Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N126

Enrollment

Registered

2024-11-24

Start date

2024-12-10

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

In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug Lithium carbonate 300 mg Tablets manufactured by Mofid Pharmaceutical Company in the first period. Intervention 2: Control group: Singl

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0,1,1.5,2,2.5,3,3.5,4,6,8,1,12,24,48,72 h after drug adminstration. Method of measurement: HPLC-MS/MS.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

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