BIOEQUIVALENCE STUDY OF RETAPHYL (THEOPHYLLINE) 300 MG SUSTAINED RELEASE CAPLET PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (NUELIN™-SR 300 SUSTAINED RELEASE TABLET PRODUCED BY ADCOCK INGRAM LIMITED, INDIA FOR INOVA PHARMACEUTICALS (S) PTE LTD) WHEN ADMINISTERED UNDER FASTING CONDITION IN HEALTHY SUBJECTS

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-D6RYET3
Tanggal Input Registry : 22-07-2024

11-05-2023
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
BIOEQUIVALENCE STUDY OF RETAPHYL (THEOPHYLLINE) 300 MG SUSTAINED RELEASE CAPLET PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (NUELIN™-SR 300 SUSTAINED RELEASE TABLET PRODUCED BY ADCOCK INGRAM LIMITED, INDIA FOR INOVA PHARMACEUTICALS (S) PTE LTD) WHEN ADMINISTERED UNDER FASTING CONDITION IN HEALTHY SUBJECTS
BIOEQUIVALENCE STUDY OF RETAPHYL (THEOPHYLLINE) 300 MG SUSTAINED RELEASE CAPLET PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (NUELIN™-SR 300 SUSTAINED RELEASE TABLET PRODUCED BY ADCOCK INGRAM LIMITED, INDIA FOR INOVA PHARMACEUTICALS (S) PTE LTD) WHEN ADMINISTERED UNDER FASTING CONDITION IN HEALTHY SUBJECTS
Interventional
Retaphyl SR tablet 300 mg manufactured by PT Kimia Farma Tbk
20
 

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 screening and could be considered healthy based on the evaluation. 3.Aged 18 – 55 years inclusive. 4.Non-smokers of any containing tobacco or nicotine products (cigarettes, patch, lozenges, gum, etc.). 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 theophylline or other xanthine derivatives 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.Positive result for COVID-19 rapid antigen test. 7.Clinically significant hematology abnormalities. 8.Clinically significant electrocardiogram (ECG) abnormalities. 9.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. 10.Past history of anaphylaxis or angioedema. 11.History of drug or alcohol abuse within 12 months prior to screening for this study. 12.Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 13.History of any bleeding or coagulative disorders. 14.History of seizure disorders. 15.History of cardiac arrhythmias (not including bradyarrhytmias). 16.Presence of difficulty in accessibility of veins in left or right arm during screening. 17.A donation or significant blood loss within 90 days before this study’s first dosing day. 18.Intake of any prescription drug (especially theophylline or other xanthine derivatives), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day. 19.Heavy xanthine-containing beverages drinker (e.g. coffee, tea, chocolate, or carbonate drinks) for 5 or more cups per day. 20.Difficulty in swallowing solids like tablets and capsules. This study was carried out in accordance with GCP standards. Approval from the Ethics Committee was sought prior to the conduct of the study.
 
KET-445/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Vicky Achmad Ginanjar, Pharm, B.Pharm, Co-Investigators PT Equilab International