Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

NCT00477126 | Completed Phase 1 DMC

• 1 other identifier: HIV-NAT 037
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

ritonavir generic capsule; Norvir®; Thailand; Determine bioequivalence between Norvir and GPO ritonavir

Outcome Measures

Primary Outcomes (1)

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

  2 months

Secondary Outcomes (1)

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

  2 months

Study Arms (2)

1

ACTIVE COMPARATOR

start generic product cross over to reference product

Drug: GPO ritonavir versus Norvir

2

ACTIVE COMPARATOR

start reference product cross over to generic product

Drug: GPO ritonavir versus Norvir

Interventions

GPO ritonavir versus Norvir DRUG

RTV generic compared to reference drugs (Norvir, Abbott)

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• The Government Pharmaceutical Organization: collaborator

Study Sites (1)

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

Bangkok, Bangkok, 10330, Thailand

Location

Related Links

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

Study Officials

• Kiat Ruxrungtham, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2007
• First Posted: May 22, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

TH (1)