Bioequivalence Study of Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries Compared to Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-9F4KMB3
Tanggal Input Registry : 24-08-2023

19-10-2022
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10, and 12 hours after drug administration (15 time points) after drug administration] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 12 hours (AUCt) [[time points : 0 hours (before drug administration); 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10, and 12 hours after drug administration (15 time points) after drug administration] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries Compared to Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc.
Bioequivalence Study of Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries Compared to Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc.
Interventional
The reference drug was Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc, batch number 21119QA, manufacturing date on March 2020, expired date on February 2023. The test drug was Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries, batch number 2107-01-273A, manufacturing date July 2021, Expired date July 2023. In sampling day, subject took one dose of Lansoprazole manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position.
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Inclusion Criteria:

Inclusion criteria in this study include: a. Sign informed consent b. Healthy, based on clinical laboratory tests (routine hematology, liver function, kidney function, blood sugar, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination; c. Male and female subjects (if female, consider the risk in women of childbearing age and take a pregnancy test); d. Age between 18 - 55 years; e. Body weight is within the normal range according to the Body Mass Index (BMI) 18 - 25 kg/𝑚2; f. Vital signs were in the following range systolic blood pressure 110 - 129 mmHg, diastolic blood pressure 70 - 84 mmHg, pulse within the normal range 60 - 90 bpm, check oxygen saturation (SpO2) within the normal range 95-100%, and heart rate breathing within the normal range of 12-20/min;

Exclusion Criteria:

Exclusion criteria in this study include: a. Smoking more than 10 cigarettes per day; b. Pregnant or nursing women. A pregnancy test is carried out first at the time of screening and before administering the test drug or comparator c. Have a history of kidney and liver disease, and have a history of allergies or hypersensitivity or contraindications to the bioequivalence test drug (Lansoprazole); d. Clinically significant haematological abnormalities; e. Electrocardiogram (ECG) abnormalities; f. Difficulty in venous accessibility in the left or right arm; g. History of ongoing serious illness or chronic disease that is clinically or medically significant; h. History of drug or alcohol abuse in the 12 months (1 year) prior to screening for this study; i. Positive serological tests include Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); j. The test result of the SARS-CoV-2 antigen rapid test is positive (if the BE test is carried out during a pandemic); k. Have a history or condition that may affect the kinetics of the drug; l. Using drugs or food supplements no more than 7 days since the study began; m. Participated in a previous clinical trial no later than 3 months from the time the study started; n. Blood donation or blood loss of more than 300 ml less than 3 months from the start of the study.
 
KET-907/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T