Cysteamine, Bioequivalence, pharmacokinetics.
Conditions
Interventions
Intervention 1: Intervention group: 150 mg Capsule of Cysteamod® (Modava pharmaceutical company), once daily. Intervention 2: Control group: 150 mg Capsule of Cystagon® (Mylan Pharmaceuticals), once d
Sponsors
Modava Pharmceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drug or related products Significant history or presence of gastrointestinal, kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications Significant history of asthma, chronic bronchitis or other bronchospastic condition Any clinically significant illness during the 4 weeks prior to day of this study Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease Participation in a clinical trial with an investigation drug within 30 days preceding day 1 of this study Use of enzyme- modifying drugs within 30 days prior to day 1 of this study Use of any systemic medication (including OTC preparations) within 14 days prior day 1 of this study HIV and Hepatitis B and anti HCV antibody positive subjects Smoking History of difficulty in donating blood Donation of blood within 90 days before first dosing History of vaccination within one month before first dosing Significant history or presence of glaucoma, cardiovascular or hematological disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood plasma. Timepoint: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours after administration. Method of measurement: Blood test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak plasma concentration. Timepoint: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours. Method of measurement: Blood test.;Maximum plasma concentration. Timepoint: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours. Method of measurement: Blood test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Dibaei
Modava pharmaceutical company
Outcome results
None listed