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

NCT00622141 | Withdrawn Phase 1

• 1 other identifier: HIV-NAT 038
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections

Keywords

bioequivalence; ritonavir boosted generic GPO saquinavir; saftey; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug.

  8 days

Secondary Outcomes (1)

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

  8 days

Study Arms (2)

A

ACTIVE COMPARATOR

Day 1: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg 7-day washout period will follow. Day 8: take generic GPO squinavir/Norvir

Drug: generic GPO saquinavir and novir vs invirase and norvir

B

ACTIVE COMPARATOR

Day 1: take generic GPO squinavir/Norvir 7-day washout period will follow. Day 8: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg

Drug: generic GPO saquinavir and novir vs invirase and norvir

Interventions

generic GPO saquinavir and novir vs invirase and norvir DRUG

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

A; B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• The Government Pharmaceutical Organization: collaborator

Related Links

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

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kiat Ruxrungtham, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Last Updated: March 26, 2015

Record last verified: 2015-03