Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Study Overview
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Brief Summary
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To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: GPO ritonavir versus Norvir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>start generic product cross over to reference product | Drug: GPO ritonavir versus Norvir<br>* RTV generic compared to reference drugs (Norvir, Abbott)<br>|
| Active Comparator: 2<br>start reference product cross over to generic product | Drug: GPO ritonavir versus Norvir<br>* RTV generic compared to reference drugs (Norvir, Abbott)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers. |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ritonavir generic capsule, Norvir®, Thailand, Determine bioequivalence between Norvir and GPO ritonavir