Bioequivalence Study of Pioglitazone 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Actos® 30 mg Tablet (Innovator) Manufactured by PT. Takeda Indonesia License from Takeda Pharmaceuticals COmpany Limited. Osaka, Japan.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
NA-D16E5G3
Tanggal Input Registry : 30-08-2024

30-05-2022
AUC0-t , Cmax
AUC0-inf , tmax, half life
 
Bioequivalence Study of Pioglitazone 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Actos® 30 mg Tablet (Innovator) Manufactured by PT. Takeda Indonesia License from Takeda Pharmaceuticals COmpany Limited. Osaka, Japan.
Bioequivalence Study of Pioglitazone 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Actos® 30 mg Tablet (Innovator) Manufactured by PT. Takeda Indonesia License from Takeda Pharmaceuticals COmpany Limited. Osaka, Japan.
Interventional
Pioglitazone 30 mg Tablet manufactued by PT Kimia Farma tbk, Indonesia
30
 

Inclusion Criteria:

The inclusion criteria for this study include: 1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2); 6) Vital signs within the following ranges: systolic blood pressure 100- 129 mmHg, diastolic blood pressure 60-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperature

Exclusion Criteria:

The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests will be performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Pehadoxin Forte Tablet (Isoniazid 400 mg + Vitamin B6 10 mg)); 4) Clinically significant (routine hematology, liver function, kidney function, blood glucose, urinalysis) abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV). 10) History or condition that can affect drug kinetics. 11) Use of drugs or dietary supplements no more than 7 days since the start of the study. 12) Participation in previous clinical trials no more than 3 months from the start of the study. 13) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study.
 
KET-51/UN2.F1/ETIK/PPM.00.02/2022 (17 Jan 2022) & S-304/UN2.F1/ETIK/PPM.00.02/2022 (25 Apr 2022)
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T (lab.equitrust@gmail.com)