Clinical bioequivalence study of Nevirapine Prolonged Release Tablets 400 mg in HIV-1 infected patients
- Conditions
- Health Condition 1: null- HIV-1 Infected
- Registration Number
- CTRI/2018/01/011185
- Lead Sponsor
- APL Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI >= 18.5 to <= 30 kg/m2.
2.Non smokers and non alcoholics.
3.Subject with a stable Nevirapine based combination antiretroviral regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and Efavirenz) that is recommended according to British HIVAssociation clinical guidelines:
a. Abacavir and lamivudine {ABC/3TC} as fixed dose combination
b. Tenofovir and emtricitabine {TDF/FTC}
c. Zidovudine and lamivudine {AZT/3TC}, OR
d. Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study.
4.Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease.
5.Subjects with An HIV viral load < 50 copies/mL in preceding 12 months and at screening.
6.Subjects with a CD4+ Tcell count > 50 cell/mm3 in preceding 12 months and at screening.
7.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
8.Subject with no history of addiction to any recreational drug or drug dependence
9.Acceptable screening laboratory values that indicate adequate baseline organ function.
10.Willingness to abstain from ingesting medications that are listed as contraindicated for Nevirapine during the whole course of the study.
11.Capable of completing patient diaries.
12.Capable and willing to come back for PK assessments and follow up.
13.Willingness to refrain from excessive physical activity during the trial.
14.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
15.Female subject of childbearing potential should be willing to use a reliable method of birth control
16.Female subject must have a negative pregnancy test at Screening.
1.Subject Current treatment with an HIV protease inhibitor
2.Subject had Infection with HIV2 or HIV1 group O.
3.Subject Laboratory parameters > DAIDS grade 2 Coagulation.
4.Subject Laboratory parameters > DAIDS grade 2 Total triglycerides
5.Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine and/or the background antiretroviral HIV therapy)
6.Intake of products containing St. Johns Wort from 14 days before treatment with study medication (Day 1) and not willing to abstain from it throughout the study until completion of the study
7.Subject undergone major surgery within 4 weeks of enrolment.
8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc
9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
10.High caffeine (more than 5 cups of coffee or tea/day) consumption.
11.Subject diagnosed to be Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
12.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
13.Female subject who is pregnant or currently breast-feeding.
14.Subject donated blood >= 350 mL within 90 days of screening.
15.Subject participation in another clinical trial within the preceding 90 days of study starts.
16.Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
17.Subject with history of arterial thrombosis or deep vein thrombosis within the past year.
18.Patients on Tuberculosis treatment with Rifampicin
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-tau: Area under the plasma concentration â?? <br/ ><br>time curve over the steadystate dosing interval. <br/ ><br>Cmax-ss: Maximum concentration over the <br/ ><br>steady state dosing interval. <br/ ><br>Ctau: Concentration at the end of dosing intervalTimepoint: Predose sample will be collected within 5 minutes prior to dosing on Day 1, 12, 13 & 14 in Period I and <br/ ><br>on Day 15, 26, 27 and 28 in Period II. On Day 14 <br/ ><br>and Day 28, post dose samples will be <br/ ><br>collected at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, <br/ ><br>7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00 and <br/ ><br>24.00 hours
- Secondary Outcome Measures
Name Time Method Css-avg,Percentage fluctuation, Tmax ss and <br/ ><br>Cmin-ss, Safety and tolerabilityTimepoint: Predose will be collected within 5 minutes prior <br/ ><br>to dosing on Day 1, 12, 13 & 14 in Period I and on Day 15, 26, 27 and 28 in Period II. On Day 14 and Day 28, post dose samples will be <br/ ><br>collected at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours