Bioequivalence Study of Nevirapine 200 mg Caplet Manufactured by PT. Kimia Farma Tbk in Comparison with Viramune® 200 mg Caplet Manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-XMFSGW8
Tanggal Input Registry : 02-02-2023

04-06-2021
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of Nevirapine 200 mg Caplet Manufactured by PT. Kimia Farma Tbk in Comparison with Viramune® 200 mg Caplet Manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
Bioequivalence Study of Nevirapine 200 mg Caplet Manufactured by PT. Kimia Farma Tbk in Comparison with Viramune® 200 mg Caplet Manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
Interventional
Subjects are given a single dose of 1 caplet of Nevirapine 200 mg of either formulation (test or reference) with 240 ml of water.
16
 

Inclusion Criteria:

The inclusion criterias are healthy male or female subjects who/with: - have read the subject information and signed informed consent documents - healthy male or female - age between 18 – 55 years - body mass index between 18–25 kg/m2 - have a normal electrocardiogram - blood pressure within normal range (90-120 mmHg for systolic blood pressure and 60-80 mmHg for diastolic blood pressure) - heart rate within normal range (60-100 bpm) - have no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening - acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

Any of the following criterias will exclude the subject from the study: - those who are pregnant and/or nursing woman - those with history of hypersensitivity to nevirapine, or other antiretroviral, or to other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction, or active allergic - those who have a history or presence medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic insufficiency or cardiovascular disease - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities - those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within 1 week prior to the drug administration day - those who have participated in any clinical study within 3 months prior to the study (< 90 days) - those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study - those who smoke - those with history of travelling to another city within last 14 days - those with history of direct contact with a COVID-19 positive person in the subject neighborhood - those with history or present of sore throat, fever (with temperature more than 37°C) or short of breath with in last 14 days - those who are positive to rapid antigen test of SARS CoV-2 - those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential) - those with a history of drug or alcohol abuse within 12 months prior to screening for this study - those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1241/UN2.F1/ETIK/PPM.00.02/2019
478/STD/PML/2019
Nabila