Bioequivalence study of Generic Co-trimoxazole ??? mg/ ?ml Suspension versus Bactrim ® ??? mg/ ?ml (Mutual Pharmaceutical Company) Suspension after single oral dosing in healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Receives one spoon of test drug (Generic Co-trimoxazole ??? mg/ ?ml Suspension). Blood samples were taken from the volunteers for 72 hours at the mentioned times af
Sponsors
nik saman darou
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Being male Being at the age of 18 to 55 years old. Weight in range of 10 % of proper body weight. All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test. Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Exclusion criteria
Exclusion criteria: Volunteers with hypersensitivity to Co-trimoxazole Those with known history of drug abuse, alcohol consuming or cigarette smoking. Taking medications that have drug interactions with Co-trimoxazole until one month before studying. Disinclination to take the test. Blood donation or blood loss of more than 200 ml in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma samples. Timepoint: In times 0, 0/33, 0/66, 1, 1/5, 2, 2/5, 3, 3/5, 4, 4/5, 5, 6, 8, 11, 24, 32, 48, 72 Hours after the start of the intervention. Method of measurement: Chromatography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBardia Jamali
Tam Pouya Consulting & Research Company
Outcome results
None listed