Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fed Condition
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Vital signs within normal ranges.
- Ethnic Group: Arab & Mediterranean.
- Normal Kidney & Liver functions test
- ...
- Vital signs within normal ranges.
- Ethnic Group: Arab & Mediterranean.
- Normal Kidney & Liver functions test
- Healthy subjects.
- Age 18-50 years.
- Subject is available for the whole study period and gave written informed consent.
- All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
- Race: Mixed skin (white & black skin people).
- Normal Physical examination.
- Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Exclusion Criteria
- Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
- Vomiting, Diarrhea on admission
- Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- ...
- Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
- Vomiting, Diarrhea on admission
- Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- Abnormal Kidney and/or Liver functions test.
- Smoking of more than 10 cigarettes per day
- Clinically significant illness 4 weeks before study Period I
- Subjects with history of Liver disease.
- Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
- Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
- Ethnic Group (Non- Arab &/ or Non- Mediterranean)
- Abnormal Vital Signs.
- Regular use of medication.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- 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
- Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine and methadone) during one month before the study initiation.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
- Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
- Presence of any significant physical or organ abnormality
- History of severe allergy or allergic reactions to study drug or related drugsor heparin
- Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
- Subjects with seizures or prior history of seizures.
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
- Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Mental disease.
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
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 o...
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).
Inclusion Criteria
- Vital signs within normal ranges.
- Ethnic Group: Arab & Mediterranean.
- Normal Kidney & Liver functions test
- ...
- Vital signs within normal ranges.
- Ethnic Group: Arab & Mediterranean.
- Normal Kidney & Liver functions test
- Healthy subjects.
- Age 18-50 years.
- Subject is available for the whole study period and gave written informed consent.
- All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
- Race: Mixed skin (white & black skin people).
- Normal Physical examination.
- Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Exclusion Criteria
- Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
- Vomiting, Diarrhea on admission
- Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- ...
- Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
- Vomiting, Diarrhea on admission
- Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- Abnormal Kidney and/or Liver functions test.
- Smoking of more than 10 cigarettes per day
- Clinically significant illness 4 weeks before study Period I
- Subjects with history of Liver disease.
- Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
- Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
- Ethnic Group (Non- Arab &/ or Non- Mediterranean)
- Abnormal Vital Signs.
- Regular use of medication.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- 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
- Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine and methadone) during one month before the study initiation.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
- Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
- Presence of any significant physical or organ abnormality
- History of severe allergy or allergic reactions to study drug or related drugsor heparin
- Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
- Subjects with seizures or prior history of seizures.
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
- Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Mental disease.
Tracking Information
- NCT #
- NCT02185846
- Collaborators
- Abdi Ibrahim Ilac San. ve Tic A.S.
- Investigators
- Principal Investigator: Rana T Bustami, Phd.pharmacy PRU
- Rana T Bustami, Phd.pharmacy PRU