Comparative, Randomized, Two -Period, Two-treatment, Two -Sequence, Open Label, Crossover Bioequivalence Pilot Study of Dirithromycin 500 mg Enteric Coated Tablet (One Tablet) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) Versus Dynabac 250 mg Enteric Coated Tablet (Two Tablets) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions.
Overview
- Phase
- Phase 1
- Intervention
- DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
- Conditions
- Healthy
- Sponsor
- Pharmaceutical Research Unit, Jordan
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- AUC Ratio
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.
Detailed Description
An open-label, randomized, two-treatments, two-periods, two-sequences, crossover bioequivalence pilot study with a washout period of at least 14 days between doses. Healthy, mixed skin Arab \& Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of not more than 10 cigarettes per day).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects.
- •Ethnic Group: Arab \& Mediterranean.
- •Race: Mixed skin (white \& black skin people).
- •Age 18-50 years.
- •Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
- •Subject is available for the whole study period and gave written informed consent.
- •Normal Physical examination.
- •Vital signs within normal ranges.
- •All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
- •Normal Kidney \& Liver functions test
Exclusion Criteria
- •Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
- •Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
- •History of severe allergy or allergic reactions to study drug or related drugs or heparin
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •History of serious illness that can impact fate of drugs
- •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
- •Clinically significant illness 4 weeks before study Period I
- •Mental disease.
- •Smoking of more than 10 cigarettes per day
- •Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
Arms & Interventions
DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once
Intervention: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
DYNABAC 250 MG ENTERIC COATED TABLET
DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once
Intervention: DYNABAC 250 MG ENTERIC COATED TABLET
Outcomes
Primary Outcomes
AUC Ratio
Time Frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing
The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00%based on Erythromycylamine.
Cmax Ratio
Time Frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing
The 90% confidence interval for this measure lies within an acceptance range of 80.00%-125.00% based on Erythromycylamine.