En The study uses healthy men volunteers aged 18-60..
Conditions
Interventions
Intervention 1: Control group: The control group in this study is to investigate the bioequivalence of Primidone Suspension 62.5 mg/2.5 ml 250 ml Pharmaceutical Company Sina Pishgam Daru Novina Pharma
Sponsors
Sina Pishgam Daru Novin Company
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Have good general health (liver, heart, and kidneys).Body mass index is (18-28).Informed consent will be obtained. Ages are (18-60 years).
Exclusion criteria
Exclusion criteria: Allergy to this drug or other drugs and substances Pregnancy or planning to become pregnant Breastfeeding or having a mood or mental disorder (such as depression, suicidal thoughts) Lung problems (such as sleep apnea, chronic obstructive pulmonary disease (COPD)) Liver problems Kidney problems Certain hormone problems (adrenal disease such as Addison's disease) Personal or family history of porphyria Deficiency of certain vitamins in the body (vitamin K, folic acid) Personal or family history of a substance use disorder (such as overuse or addiction to drugs or alcohol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration. Timepoint: In 15 time point 0 , 1 ,1.5 , 2 , 2.5 , 3 , 53. , 4 , 5 , 6 , 7 , 8 , 10 , 12 , 24 48. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDarush Omidfar
Payesh Darou Zist Azma
Outcome results
None listed