Recruitment

Recruitment Status
Completed

Inclusion Criteria

Healthy subjects.
Normal Kidney & Liver functions test
Subject is available for the whole study period and gave written informed consent.
...
Healthy subjects.
Normal Kidney & Liver functions test
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.
Normal Physical examination.
Ethnic Group: Arab & Mediterranean.
Vital signs within normal ranges.
Age 18-50 years.
Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Race: Mixed skin (white & black skin people).

Exclusion Criteria

Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
Abnormal Vital Signs.
Vomiting, Diarrhea on admission
...
Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
Abnormal Vital Signs.
Vomiting, Diarrhea on admission
Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
Abnormal Kidney and/or Liver functions test.
Mental disease.
Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
Presence of any significant physical or organ abnormality
Regular use of medication.
Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
Subjects with seizures or prior history of seizures
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Clinically significant illness 4 weeks before study Period I
Smoking of more than 10 cigarettes per day
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
History of severe allergy or allergic reactions to study drug or related drugs or heparin
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.
Ethnic Group (Non- Arab &/ or Non- Mediterranean)
Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
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

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

Healthy subjects.
Normal Kidney & Liver functions test
Subject is available for the whole study period and gave written informed consent.
...
Healthy subjects.
Normal Kidney & Liver functions test
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.
Normal Physical examination.
Ethnic Group: Arab & Mediterranean.
Vital signs within normal ranges.
Age 18-50 years.
Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Race: Mixed skin (white & black skin people).

Exclusion Criteria

Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
Abnormal Vital Signs.
Vomiting, Diarrhea on admission
...
Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
Abnormal Vital Signs.
Vomiting, Diarrhea on admission
Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
Abnormal Kidney and/or Liver functions test.
Mental disease.
Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
Presence of any significant physical or organ abnormality
Regular use of medication.
Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
Subjects with seizures or prior history of seizures
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Clinically significant illness 4 weeks before study Period I
Smoking of more than 10 cigarettes per day
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
History of severe allergy or allergic reactions to study drug or related drugs or heparin
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.
Ethnic Group (Non- Arab &/ or Non- Mediterranean)
Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
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

Tracking Information

NCT #
NCT02185833
Collaborators
Abdi Ibrahim Ilac San. ve Tic A.S.
Investigators
  • Principal Investigator: Rana T Bustami, Phd.pharmacy PRU
  • Rana T Bustami, Phd.pharmacy PRU
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