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Bioequivalence Study of Generic GPO Ritonavir Versus Norvir�

Information source: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: GPO ritonavir versus Norvir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: The HIV Netherlands Australia Thailand Research Collaboration

Official(s) and/or principal investigator(s):
Kiat Ruxrungtham, MD, Principal Investigator, Affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Summary

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

Clinical Details

Official title: Bioequivalence Study of Generic GPO Ritonavir Versus Norvir in Thai Healthy Volunteers

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

Primary outcome: Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand
Additional Information

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

Starting date: January 2007
Last updated: April 3, 2012

Page last updated: August 23, 2015

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