Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ritonavir ...
  • Study Participants

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.
Study Started
Jan 31
Primary Completion
Feb 28
Study Completion
Feb 28
Last Update
Apr 05

Drug GPO ritonavir versus Norvir

RTV generic compared to reference drugs (Norvir, Abbott)

1 Active Comparator

start generic product cross over to reference product

2 Active Comparator

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
No Results Posted