Healthy
Conditions
Keywords
ritonavir generic capsule, Norvir®, Thailand, Determine bioequivalence between Norvir and GPO ritonavir
Brief summary
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
Detailed description
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.
Interventions
DRUGGPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)
Sponsors
The Government Pharmaceutical Organization
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers. | 2 months |
Countries
Thailand
Outcome results
None listed