Health Condition 1: null- HIV Patients
Conditions
Interventions
Intervention1: Nevirapine Tab.: Nevirapine Extended Release Tablet 400 mg of Hetero lab. Oral, Once daily for 08 Days
Control Intervention1: Viramune® XR: Viramune 400 mg prolonged-release tablets o
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: •HIV-I infected adult male or non-pregnant, non-lactating female patients, 18-45 years of age (both inclusive). •Subjects willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent. •BMI 18.5-30 kg/m2, diagnosed with documented HIV-I infection. •Patient who is already receiving Nevirapine 400 mg per day in combination with at least two antiretroviral drugs for at least 14 days prior to first IMP administration. •An HIV viral load •CD4 counts >50/mm3 at screening •History of adequate renal, hepatic and cardiac function
Exclusion criteria
Exclusion criteria: •A history of allergic or adverse reactions to Nevirapine or any comparable or similar product. •Current treatment with an HIV protease inhibitor. •Patients with moderate or severe hepatic impairment Child Pugh B or C. •Screening AST or ALT > 2.5 ULN. •History of liver function abnormalities upon re-administration of Nevirapine. •History or presence of cancer. •Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine within 14 days prior to first dosing. •Difficulty in swallowing solids like tablets or capsules. •Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery. •Patients with known positivity for HbsAg and HCV. •An unusual or abnormal diet, for whatever reason e.g. religious fasting. •Subject participating in any other clinical study or has received treatment with any investigational drug or device within 90 days prior to first dose of investigational medicinal product for the current study. •Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study. •History of difficulty with donating blood or difficulty in accessibility of veins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-Ï?), Cmax,ss, CÏ?,ss, tmax,ss, Cmin, ss and fluctuation for NevirapineTimepoint: predose 0.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 21.00, 22.00 23.00 and 24.00 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety & tolerability of the patientsTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sagar Bhosale
CRBio ( A Division of RA CHEM PHARMA)
Outcome results
None listed