Title
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
RTV generic compared to reference drugs (Norvir, Abbott)
start generic product cross over to reference product
start reference product cross over to generic product
Inclusion Criteria: Written informed consent Healthy male or female 18-45 years old Documented negative test for HIV-1 infection < 1 wk prior to start of study and with no risk of HIV exposure in the last 6 months For female subjects: documented negative pregnancy test <3 wk prior to start of study, not breastfeeding BMI 18-25 Normal physical examination Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection Exclusion Criteria: History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. Inability to understand the nature and extent of the study and the procedures required. Participation in a drug study within 60 days prior to the first dose. Febrile illness within 3 days before the first dose. Use of concomitant medication Smoke cigarettes not more than 10 cigarettes a day. Drink alcohol not more than 2 units a day Discontinue smoking and alcohol for at least 1 month before enrollment. Take other medication regularly Involvement in any drug addiction Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
