Bioequivalence study comparing Nevirapine Prolonged Release 400 mg tablets (Mylan Laboratories Limited) to reference drug Viramune Prolonged-Release Tablets 400 mg under fasting conditions in adult HIV-I Infected Patients stabilized on Nevirapine

Active, not recruiting

• Conditions: HIV-I Infected patients

• Registration Number: CTRI/2015/02/005493
• Lead Sponsor: MYLAN LABORATORIES LIMITED

Brief Summary

The sponsor has developed thetest formulation. This study is being conducted to compare the bioavailabilityand characterize the Pharmacokinetic profile of the  sponsor’s formulatons (Nevirapine Prolonged Release 400 mg tablets) withreference formulation (VIRAMUNE Prolonged Release 400 mg tablets) in HIV-I Infected patientsunder fasting conditions, stabilized on Nevirapinebased regimen either immediate release or prolonged release to assess thebioequivalence. The most serious adverse reactions associated withnevirapine are hepatitis, hepatic failure, Stevens- Johnson syndrome, toxicepidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failuremay be isolated or associated with signs of hypersensitivity which may includesevere rash or rash accompanied by fever, general malaise, fatigue, muscle orjoint aches, blisters, oral lesions, conjunctivitis, facial edema,eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunctionetc.,   regulatory authorities arerecommending that studies should be conducted on  HIV-I infected patients.    Since the formaulation being studied is a modifiedrelease formaulation, a multiple dose, stady state study is being conducted asper applicable regulatory guidance. The study is being conducted onschizophrenic patients who are on a stable dose of Nevirapine based regimen,and the patient cannot be deprived of the Nevirapine treatment during thewashout period of the study. Hence, the study has been planned to be acontinuous administration of the test and reference formulation without anyintervening washout period. Objective: To evaluate the pharmacokineticbioequivalence of the test and reference products and to monitor safety of thepatients. The total number of patients to enroll is around 36 from India.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 1.Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulatory requirements.
• 2.Male and Non pregnant, non-lactating female subjects 18-65 years of age with documented HIV-I infection 3.BMI 18.5-30 mg/m2 4.Already receiving stable Nevirapine based regimen either immediate release or prolonged release (for at least 14 days) in combination with: a.Zidovudine and Lamivudine or b.Tenofovir and Lamivudine as separately prescribed components and to be kept constant throughout the study 5.An HIV viral load < 50 copies/mL at screening 6.A CD4+ T cell count > 50 cell/mm3.

Exclusion Criteria

1.History of allergy or hypersensitivity reactions to Nevirapine or the ingredients of the formulation 2.Current treatment with an HIV protease inhibitor 3.Clinically significant cardiac, liver or kidney disease 4.Having moderate to severe renal dysfunction or serum creatinine > 3 X ULN 5.Females who have a positive pregnancy test during screening or breast feeding or subjects not willing to take appropriate contraceptive measures to prevent pregnancy during the study 6.Patients with severe hepatic impairment (Child-Pugh C) 7.ALT or AST > 3 X ULN, Bilirubin > 2 X ULN 8.Any contraindication to use of Nevirapine 9.Past history or currently suffering from tuberculosis 10.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion 11.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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmaxss, AUCtau, Tmaxss, Cminss, Ctauss, Cavss and % Fluctuation for Nevirapine	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 after post dose

Trial Locations

Locations (6)

Kasturba Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Medilink Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Mysore Medical College; 🇮🇳 Mysore, KARNATAKA, India

Sapthagiri Institute of Medical Sciences and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Surakshaka Diabetic Centre (P) Ltd; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Unique Hospital; 🇮🇳 Surat, GUJARAT, India

Kasturba Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr John Thomas Ramapuram

Principal investigator

08242425092

john@ramapuram.net