Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®

HIV Infections Clinical Trial

Official title:

Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir® in Thai Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00622141
• Other study ID #: HIV-NAT 038
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: February 12, 2008
• Last updated: March 24, 2015

Study information

• Verified date: March 2015
• 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

The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.

Description:

The primary objective is to establish bioequivalence of "ritonavir boosted generic GPO saquinavir", with Invirase® and Norvir® as the reference drug.

The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Healthy male 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

• 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: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• generic GPO saquinavir and novir vs invirase and norvir
Norvir® 100mg capsules, Invirase® 1,000 mg capsules Generic GPO Saquinavir 1,000 mg capsules For phase 1 and 2 - At day 1 subjects of group A will receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg, while group B will receive generic GPO saquinavir / Norvir® 1,000 mg / 100mg as single dose. The same day the first 24 hr PK curve will be done. After this, a 7-day washout period will follow. At day 8 group A will take generic GPO saquinavir / Norvir® and Group B will take Invirase®/Norvir®. At this day, the second 24 hr PK curve will be done

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug.		8 days	No
Secondary	The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.		8 days	Yes

External Links

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