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CompletedNCT00477126Updated Apr 5, 2012

Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

A Phase 1 interventional study of GPO ritonavir versus Norvir in Healthy, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Completed at 1 site in Thailand. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-05.

Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • ritonavir generic capsule
  • Norvir®
  • Thailand
  • Determine bioequivalence between Norvir and GPO ritonavir
03

In context

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration is the lead sponsor of 59 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    1

    start generic product cross over to reference product

    Drug: GPO ritonavir versus Norvir

  • Active comparator
    2

    start reference product cross over to generic product

    Drug: GPO ritonavir versus Norvir

Interventions

  • DrugGPO ritonavir versus Norvir

    RTV generic compared to reference drugs (Norvir, Abbott)

06

What researchers measure

Primary outcomes

  1. Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.

    Time frame: 2 months

Secondary outcomes

  1. Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.

    Time frame: 2 months

07

Study locations

1 site
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
    Bangkok, 10330, Thailand
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00477126
Lead sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
The Government Pharmaceutical Organization
First posted
May 22, 2007
Start date
Jan 2007
Primary completion
Feb 2007
Completion
Feb 2007
Last update
Apr 5, 2012

Study contacts

Kiat Ruxrungtham, MD
principal investigator · The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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