A crossover bioequivalence study in 24 healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Oral administration of one tablet of Carvedilol 12.5 mg manufactured by Shafa Company to 12 healthy volunteers with 240 ml of water half an hour after eating breakf
Sponsors
Shafa Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy male or female volunteers Body mass index (BMI) between 18 - 30 Volunteers who are willing to sign an informed consent form
Exclusion criteria
Exclusion criteria: Familial history of heart disease History of allergy to Carvedilol or formulation components History or significant clinical evidence of any disease Taking any type of medicine in the 14 days before the start of the study Participation in any clinical study within 30 days prior to study initiation Systolic blood pressure less than 11 and diastolic less than 7 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Liquid chromatography with mass spectrophotometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration and then calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Talari
Kharazmi Plasma Center
Outcome results
None listed