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OpenTrials
Completed

NCT Number: NCT00477126

Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GPO ritonavir versus Norvir

Drug

RTV generic compared to reference drugs (Norvir, Abbott)

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

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • The Government Pharmaceutical Organization

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 22, 2007
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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