Bioequivalence Study of Escitalopram 10 mg Film-Coated Tablet Produced by PT Sunthi Sepuri in Comparison with Cipralex® 10 mg Film-Coated Tablet Produced by H. Lundbeck A/S, Valby, Denmark; Registered by PT Pyridam Farma Tbk, Jakarta, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
Tanggal Input Registry : 11-09-2025

25-07-2025
AUC0-t , Cmax
AUC0-inf , tmax, half life
 
Bioequivalence Study of Escitalopram 10 mg Film-Coated Tablet Produced by PT Sunthi Sepuri in Comparison with Cipralex® 10 mg Film-Coated Tablet Produced by H. Lundbeck A/S, Valby, Denmark; Registered by PT Pyridam Farma Tbk, Jakarta, Indonesia
Bioequivalence Study of Escitalopram 10 mg Film-Coated Tablet Produced by PT Sunthi Sepuri in Comparison with Cipralex® 10 mg Film-Coated Tablet Produced by H. Lundbeck A/S, Valby, Denmark; Registered by PT Pyridam Farma Tbk, Jakarta, Indonesia
Interventional
Escitalopram 10 mg Film-Coated Tablet Produced by PT Sunthi Sepuri
16
 

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), alcohol testing, drug abuse testing (opioid, amphetamine, benzodiazepine, and cannabis), 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 and heart rate (for ECG examination) 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperature 36.5-37.5oC, and normal respiratory rate of 12- 20/min. 7)Willing to use non-hormonal contraception (during sexual intercourse) during the study for up to 14 days after the 2nd period of the study

Exclusion Criteria:

The exclusion criteria for this study include: 1)Smoking more than 10 cigarettes per day; 2)Pregnant or breastfeeding women. Pregnancy tests were 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 (Escitalopram); 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. The check is conducted using the checksubject.com system based on national identity number. 13)Blood donation or blood loss of more than 300 ml within 3 months from the start of the study
 
KET-718/UN2.F1/ETIK/PPM.00.02/2025 and S-479/UN2.F1/ETIK/PPM.00.02/2025
Not applicable
PPUK/PPUB number
(Bayu Hadi Wahyono, Pharm, B.Pharm, MPH - Study Coordinator (+62 821 2559 0521 - lab.equitrust@gmail.com)