Bioequivalence Study of Divalproex Sodium 250 mg Enteric Coated Tablet Produced by PT Ikapharmindo Putramas in Comparison with the Comparator Drug (Depakote® 250 mg Enteric Coated Tablet of PT Abbott Indonesia, Indonesia)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-57M49RQD
Tanggal Input Registry : 04-02-2025

26-08-2024
AUC0-t dan Cmax
 
Bioequivalence Study of Divalproex Sodium 250 mg Enteric Coated Tablet Produced by PT Ikapharmindo Putramas in Comparison with the Comparator Drug (Depakote® 250 mg Enteric Coated Tablet of PT Abbott Indonesia, Indonesia)
Bioequivalence Study of Divalproex Sodium 250 mg Enteric Coated Tablet Produced by PT Ikapharmindo Putramas in Comparison with the Comparator Drug (Depakote® 250 mg Enteric Coated Tablet of PT Abbott Indonesia, Indonesia)
Interventional
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (Divalproex Sodium 250 mg Enteric Coated Tablet produced by PT Ikapharmindo Putramas, Tbk.) or one comparator drug (Depakote® 250 mg Enteric Coated Tablet of PT Abbott Indonesia, Indonesia) with approximately 200 mL of water at ambient temperature.
30
 

Inclusion Criteria:

1. Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study, 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation, 3. Aged 18-55 years inclusive, 4. Preferably non-smokers or smoke less than 10 cigarettes per day, 5. Body mass index within 18 to 25 kg/m2, 6. Vital signs (after 10 minutes rest) were within the following ranges: • Systolic blood pressure : 100 – 129 mmHg • Diastolic blood pressure : 60 – 84 mmHg • Pulse rate : 60 – 90 bpm, 7. Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to divalproex sodium or allied drugs, 2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug), 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, 6. Clinically significant hematology abnormalities, 7. Clinically significant electrocardiogram (ECG) abnormalities, 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, 9.Past history of anaphylaxis or angioedema, 10.History of drug or alcohol abuse within 12 months prior to screening for this study, 11.Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, 12.History of any bleeding or coagulative disorders, 13.Presence of difficulty in accessibility of veins in left or right arm, 14.A donation or significant blood loss within 90 days before this study’s first dosing day, 15.Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day
 
KET-304/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
BE. 810/EQL/2023
Ronal Simanjuntak – PT Equilab International