HIV Infections
Conditions
Keywords
bioequivalence, ritonavir boosted generic GPO saquinavir, saftey, pharmacokinetics
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.
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.
Interventions
DRUGgeneric 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
Sponsors
The Government Pharmaceutical Organization
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug. | 8 days |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers. | 8 days |
Outcome results
None listed