Recruitment

Recruitment Status
Completed

Inclusion Criteria

Subject is available for the whole study period and gave written informed consent.
Healthy subjects.
Race: Mixed skin (white & black skin people).
...
Subject is available for the whole study period and gave written informed consent.
Healthy subjects.
Race: Mixed skin (white & black skin people).
Ethnic Group: Arab & Mediterranean.
Normal Physical examination.
Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Age 18-50 years.
All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
Vital signs within normal ranges.
Normal Kidney & Liver functions test

Exclusion Criteria

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

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

Subject is available for the whole study period and gave written informed consent.
Healthy subjects.
Race: Mixed skin (white & black skin people).
...
Subject is available for the whole study period and gave written informed consent.
Healthy subjects.
Race: Mixed skin (white & black skin people).
Ethnic Group: Arab & Mediterranean.
Normal Physical examination.
Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
Age 18-50 years.
All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
Vital signs within normal ranges.
Normal Kidney & Liver functions test

Exclusion Criteria

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

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