Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® | NCT00477126

Studies
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

NCT00477126

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Last Update Posted

Apr 5, 2012Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GPO ritonavir versus Norvir

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

May 20, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2012

Last Update Posted Date

Apr 5, 2012Estimated

Name	Class
The Government Pharmaceutical Organization	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GPO ritonavir versus Norvir	Drug	RTV generic compared to reference drugs (Norvir, Abbott)	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiat Ruxrungtham, MD	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)		Bangkok	Bangkok	10330	Thailand