Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477126
• Other study ID #: HIV-NAT 037
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2007
• Last updated: April 3, 2012
• Start date: January 2007
• Est. completion date: February 2007

Study information

• Verified date: April 2012
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)

Locations

Country	Name	City	State
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	The Government Pharmaceutical Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.		2 months	No
Secondary	Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.		2 months	No

External Links

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