Health and normal volunteers. --
Conditions
Interventions
Intervention 1: single dose, Neurontin 300 mg tablet, Pfizer Pharma Gmbh, as reference product. Intervention 2: Single dose, Gabax 300 mg, Sobhan daru company, as test product.
Treatment - Drugs
single dose, Neurontin 300 mg tablet, Pfizer Pharma Gmbh, as reference product
Single dose, Gabax 300 mg, Sobhan daru company, as test product
Sponsors
Sobhan Daru pharmaceutical company
Vice chancellor for research, Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 24 healthy male and female volunteers will participate in this study. Aged 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW Exclusion criteria: Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: hour. Method of measurement: blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters. Timepoint: after intervention. Method of measurement: theoretical and pahrmacokinetic equations. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholamreza Bahrami
Kermanshah University of Medical Sciences
Outcome results
None listed