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Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and 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: HIV Infections

Intervention: generic GPO saquinavir and novir vs invirase and norvir (Drug)

Phase: Phase 1/Phase 2

Status: Withdrawn

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

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

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

Detailed 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.

Eligibility

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

Criteria:

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

Locations and Contacts

Additional Information

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


Last updated: March 24, 2015

Page last updated: August 23, 2015

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