A multicenter, open label, balanced, randomized, two treatment, two-period crossover, multi-dose, steady state, bioequivalence study of Nevirapine 400 mg prolonged release tablets, compared to Viramune 400 mg prolonged release tablets in adult HIV1 infected patients.
- Conditions
- Health Condition 1: null- Adult HIV1 infectedpatients.
- Registration Number
- CTRI/2015/10/006244
- Lead Sponsor
- Amneal Pharmaceuticals Company GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant, non-lactating female patients, 18-65 years of age(both inclusive) & BMI 18.5-30 mg/m2, diagnosed with documented HIV-I infection.
2. Patient who is already receiving Nevirapine 400 mg per day in combination with at least two antiretroviral drugs (As mentioned in Confidential Protocol Number: 15-VIN-479 Protocol for bioequivalence study of Nevirapine 400 mg prolonged release tablets, Version 01, dated: 10-Jul-2015 Page 7 of 53 inclusion criteria no.3) for at least 14 days prior to first IMP administration and who can be switched to Nevirapine 400 mg prolonged release tablets as per Principal Investigatorâ??s discretion.
3. Background HIV therapy with a stable antiretroviral regimen that is recommended in combination with Nevirapine according to British HIV Association clinical guidelines as separately prescribed components and kept constant (in combination and dosage) throughout the whole duration of the study:
• Zidovudine and lamivudine,
• Abacavir and lamivudine,
• Tenofovir and emtricitabine,
• Tenofovir and lamivudine
4. An HIV viral load < 50 copies/mL at screening.
5. CD4 counts >50/mm3 at screening.
6. History of adequate renal, hepatic and cardiac function.
7. Subjects willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
8. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12-consecutive months, must have a negative serum or urine pregnancy test and must agree to use an effective method of avoiding pregnancy from screening, during study and up to 1 week after the last dose of study drug. Cessation of birth control after this point should be discussed with responsible physician.
9. In case of Male patients:Men whose sexual partners are women of childbearing potential must agree to use an effective method to avoid pregnancy of his partner from screening, during study & up to 1-week after last dose of study drug. Cessation of birth control after this point should be discussed with responsible physician.
1. A history of allergic or adverse reactions to Nevirapine or any comparable or similar product.
2. Current treatment with an HIV protease inhibitor.
3. Patients with moderate or severe hepatic impairment Child Pugh B or C.
4. Screening AST or ALT > 2.5 ULN.
5. History of liver function abnormalities upon re-administration of Nevirapine.
6. History or presence of cancer.
7. 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.
8. Difficulty in swallowing solids like tablets or capsules.
9. Patients who are using a prohibited contraceptive method (As per Annexure II).
10. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
11. Patients with known positivity for HbsAg and HCV.
12. An unusual or abnormal diet, for whatever reason e.g. religious fasting.
13. 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.
14. 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.
15. History of difficulty with donating blood or difficulty in accessibility of veins.
16. Tested positive for drugs of abuse or breath alcohol test at the screening visit or at the check-in visit.
17. Use of any recreational drugs or history of drug addiction.
18. Patients with severe hepatic impairment, impaired renal function, impaired cardiac function, any abnormal laboratory tests findings or any other significant concomitant disease condition which in the investigator opinion, might increase the risk to the subject or would be contraindicated or interfere with absorption of the study drug.
19. In the opinion of the Investigator, the patient will not be compliant with the requirements of the study procedures.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of the sponsorâ??s Test Product Nevirapine 400 mg prolonged release tablets) relative to that of Reference Product(Viramune 400 mg prolonged release tablets) in adult HIV1 infected. <br/ ><br>patients under fasting condition.Timepoint: pre-dose blood sample of 05 mL (00.00) will be collected within 5 minutes before dosing time on Day 12 to 14 in each period. <br/ ><br>post-dose blood samples of 05 mL each will be drawn <br/ ><br>at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 18.00, 20.00, 22.00 and 24.00 on day 14 of each period.
- Secondary Outcome Measures
Name Time Method â?¢ To monitor the adverse events and to ensure the safety & tolerability of the patients.Timepoint: NA