Study of absorption and elimination rate of Penicillamine 250-mg Capsules in comparison with Penicillamine 250-mg brand Capsules (Cupripen®).

Not Applicable

Conditions: Bioequivalence study.

Registration Number: IRCT20200407046981N49

Lead Sponsor: Vana Darou Gostar

Brief Summary: Not available

Detailed Description: Not available

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 Penicillamine or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Taking any medicine during two week before dosing

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: 0 (before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: 0 (before dosing),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.