Bioequivalence Study of Diclofenac sodium 50 mg enteric-coated tablet, Nadifen 50 manufactured by PT Global Multi Pharmalab in comparison with Diclofenac sodium 50 mg enteric-coated tablet, Voltaren ® manufactured by PT Novartis Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-HF77OE
Tanggal Input Registry : 31-08-2022

22-02-2022
AUC0-t, Cmax
AUC0-inf, Tmax, T1/2
 
Bioequivalence Study of Diclofenac sodium 50 mg enteric-coated tablet, Nadifen 50 manufactured by PT Global Multi Pharmalab in comparison with Diclofenac sodium 50 mg enteric-coated tablet, Voltaren ® manufactured by PT Novartis Indonesia.
Bioequivalence Study of Diclofenac sodium 50 mg enteric-coated tablet, Nadifen 50 manufactured by PT Global Multi Pharmalab in comparison with Diclofenac sodium 50 mg enteric-coated tablet, Voltaren ® manufactured by PT Novartis Indonesia.
Eksperimental
The reference drug was the market available Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Novartis Indonesia, batch number ID 5893; manufacturing date on April 2021; expired date on March 2024. The test drug was Nadifen (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Global Multi Pharmalab, batch number RF 08105; manufacturing date on August 2021; expired date on August 2024. In sampling day, subjects took one dose of Diclofenac Sodium products of either formulation (reference or test) with 250 mL of water according to randomization in each period in sitting position.
24
 

Inclusion Criteria:

a. Willing to participate and agree to sign the informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory rate : 12 – 20 x/minutes. (iii). Systolic blood pressure: 100 - 130 mmHg. (iv). Diastolic blood pressure: 60 - 90 mmHg. f. Have 12-lead ECG without significant abnormalities. g. Negative results of rapid test antigen Covid-19 in the screening process.

Exclusion Criteria:

a. Participate in another study within 3 (three) months before the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days before the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months before the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months before the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism, or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN).
 
KET-202/UN2.F1/ETIK/PPM.00.02/2021, S-397/UN2.F1/ETIK/PPM.00.02/2021, S-1043/UN2.F1/ETIK/PPM.00.02/2021
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RG.01.02.321.02.22.00693/UB
042/BE/OKT-2020
apt. Nada Mawaddah - Supervisor Klinis PT Biometrik Riset Indonesia