Study of absorption and elimination rate of Lithium carbonate 300-mg tablets in comparison with Lithium carbonate standard tablets manufactured by Sun Pharma.

Not Applicable

• Conditions: Bioequivalence study.

• Registration Number: IRCT20200407046981N32
• Lead Sponsor: Ahran Tejarat Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

The weight limit of each volunteer should be between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Candidates who have consented to the consent form.

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to Lithium carbonate or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two weeks before dosing.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: At 0 before dosing, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours. Method of measurement: Inductively coupled plasma spectroscopy (ICP).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 before dosing, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight.