Bioequivalence Study of Escitalopram Oxalate (Escitalopram 10 mg) Film Coated Tablet Produced by PT Nulab Pharmaceutical Indonesia, Registered by PT Nulab Pharmaceutical Indonesia in Comparison with Cipralex® (Escitalopram 10 mg) Film Coated Tablet Manufactured by H Lundbeck A/S, Valby, Denmark, Imported by PT Pyridam Farma Tbk, Jakarta - Indonesia

1. Background
Registration Number	INA-PSPGKG0
Date of registry approval	23-02-2024
Registration Date	16-02-2024
Secondary identifiers	Yes
Name of issuing authority (for example protocol number, other registries, etc)	Badan Pengawas Obat dan Makanan, Bioequivalence Study Protocol Approval No. RG.01.02.321.06.23.01829/UB
Secondary identifier number	Protocol No. 175/FORM/OMF/2023 ver 01; Report No. 132/RPT/OMF/2023 ver 00
Scientific study title	Bioequivalence Study of Escitalopram Oxalate (Escitalopram 10 mg) Film Coated Tablet Produced by PT Nulab Pharmaceutical Indonesia, Registered by PT Nulab Pharmaceutical Indonesia in Comparison with Cipralex® (Escitalopram 10 mg) Film Coated Tablet Manufactured by H Lundbeck A/S, Valby, Denmark, Imported by PT Pyridam Farma Tbk, Jakarta - Indonesia
Public (popular study title)	Bioequivalence Study of Escitalopram Oxalate (Escitalopram 10 mg) Film Coated Tablet Produced by PT Nulab Pharmaceutical Indonesia, Registered by PT Nulab Pharmaceutical Indonesia in Comparison with Cipralex® (Escitalopram 10 mg) Film Coated Tablet Manufactured by H Lundbeck A/S, Valby, Denmark, Imported by PT Pyridam Farma Tbk, Jakarta - Indonesia

2. Sponsor and Funding
Primary Sponsor	PT. Nulab Pharmaceutical Indonesia
Source(s) of monetary or material support	PT. Nulab Pharmaceutical Indonesia
Other partners	PT Omega Medika Farma Laboratori

3. Contact details
Principal Investigator
Principal investigator	apt. Noviyanto, S.Farm.
City	Jakarta
Country	Indonesia
Principal investigator's affiliation	PT Omega Medika Farma Laboratori
Principal Investigator's email address	admin@omegaresearch.id
Public Queries
Contact person name for public queries	apt. Tasha Yuliandra, M.Sc.
Address for public queries	Jalan Kramat Raya No. 61A, 10450
City	Jakarta
Country	Indonesia
ZIP	10450
Affiliation for public queries	PT Omega Medika Farma Laboratori
Email address for public queries	admin@omegaresearch.id
Phone number for public queries	0213905831
Scientific Queries
Name of Contact for scientific queries	apt. Tasha Yuliandra, M.Sc.
Address for scientific queries	Jalan Kramat Raya No. 61A, 10450
City	Jakarta
Country	Indonesia
ZIP	10450
Affiliation of scientific queries contact	PT Omega Medika Farma Laboratori
Email address for scientific queries	admin@omegaresearch.id

4. IRB & Regulatory
Ethical Approval number	No. KET-764/ UN2.F1/ETIK/PPM.00. 02/2023
Name of Ethics committee	Komite Etik Penelitian Kesehatan FK Universitas Indonesia – RSUPN Dr. Cipto Mangunkusumo
Date of Ethic approval	12-06-2023
Contact details of Ethic Committee (phone, email, and office)	Jl. Salemba Raya No. 6, Jakarta 10430, PO. BOX 1358 Gedung H Fakultas Kedokteran UI, Jalan Salemba Raya No. 6 Jakarta 10430, Po. Box 1358, Telp: 021 – 3157008 Website: komite-etik.fk.ui.ac.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	No. RG.01.02.321.06.23.01829/UB

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Jakarta
Recruitment status	Complete
Date of first enrollment	11-08-2023
Targeted Sample size	00014 -
Number of enrolled participants	14
Date of study completion (last participant, last visit)	25-08-2023

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Study in healthy human volunteers
Purpose of the study	Bioequivalence investigation
Study type	Interventional
Interventional Study category	Bioequivalence study
Method of allocation
Description of the allocation concealment mechanism and sequence generation
Masking
Study intervention (study arm)	Escitalopram Oxalate 10 mg Film Coated Tablet
Control intervention (control arm)	The design was a single dose, randomized, single-blind, two periods, crossover study, fasting condition, in male healthy subjects with two weeks washout period
Intervention assignment	Crossover

7. Eligibility Criteria
Gender inclusion criteria	Male
Minimum age	18
Maximum age	55
Inclusion criteria	Willing to sign the informed consent; Age 18 – 55 years; Body mass index between 18 – 25 kg/m2; Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute; Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood glucose, and urinalysis; history of disease, and physical examination)
Exclusion criteria	Contraindicated and/or has history of hypersensitivity to Escitalopram or related drug; With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, orthostatic hypotension, multiple syncopal episodes, epilepsy / seizure, primary psychiatric / neurological diagnosis, narrow-angle glaucoma or cardiovascular disease; Non-Healthy male (non-healthy criteria is determined by abnormal values or if outside the normal range of value and clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination); Show abnormal result or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result; Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 14 days prior to the dosing day; Participated in any clinical study within 3 months prior the study; Donated or lost 300 mL (or more) of blood within 3 months prior the study; Smoke more than 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; Indicate the positive result on test for HbsAg, Anti-HCV, and anti-HIV; With the history of alcohol and drug abuse; If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days; With history or present sore throat, fever (temperature more than 37°C) or short of breath within last 14 days; Positive to Covid-19 antigen rapid test.

8. Study Outcome
Primary Outcome
Name of primary outcome	AUCt and Cmax
Metric/method of measurement	Escitalopram concentration in plasma with LC/MS
Timepoint(s) of measurement	0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 and 72 hours after dosing
Secondary outcome 1
Name of secondary outcome 1 (SO1)	AUCinf, tmax, half-life
Metric/method of measurement (SO1)	Escitalopram concentration in plasma with LC/MS
Timepoint(s) of measurement (SO1)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 and 72 hours after dosing

9. Study Results
Brief summary of study results	From the result of study, it was concluded that Escitalopram Oxalate (Escitalopram 10 mg) film coated tablet batch number T221208 produced by PT Nulab Pharmaceutical Indonesia, registered by PT Nulab Pharmaceutical Indonesia was bioequivalent to its reference Cipralex® (Escitalopram 10 mg) film coated tablet batch number 2739378 manufactured by H. Lundbeck A/S, Valby, Denmark, imported by PT Pyridam Farma Tbk., Jakarta – Indonesia.
Date of results summaries	25-09-2023
Participant flow	NA
Baseline characteristic
Adverse events	None
Outcome measures	Geometric Mean Ratio (GMR) and 90% Confidence Interval (CI) for AUC0-t in the range of 97.87% (87.99 – 108.85%) (requirement 80.00 - 125.00%) with the intra-subject coefficient of variation is 15.78%. Geometric Mean Ratio (GMR) and 90% Confidence Interval (CI) for Cmax in the range of 99.56% (91.23 – 108.64%) (requirement 80.00 - 125.00%) with the intra-subject coefficient of variation is 12.92%.

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	No
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	-