Status:
COMPLETED
Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions
Lead Sponsor:
Pharmaceutical Research Unit, Jordan
Collaborating Sponsors:
Abdi Ibrahim Ilac San. ve Tic A.S.
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine in plasm...
Detailed Description
An open-label, randomized, two-treatments, three-periods, three-sequences, semi-replicate crossover bioequivalence study with a washout period of at least 14 days between doses. Healthy, mixed skin Ar...
Eligibility Criteria
Inclusion
- 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
- 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
- The intake of alcohol and grapefruit during the study.
- The intake of caffeine, xanthenes, or CO2-containing beverages during hospitalization.
- Regular use of medication.
- 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.
- Presence of any significant physical or organ abnormality
- 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
- Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
- Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
- Subjects with seizures or prior history of seizures.
- Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
- Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- Subjects with history of Liver disease.
- Abnormal Vital Signs.
- Abnormal Kidney and/or Liver functions test.
- Vomiting, Diarrhea on admission
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02237807
Start Date
September 1 2014
End Date
October 1 2014
Last Update
September 18 2020
Active Locations (1)
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1
Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit
Amman, Jordan, 11941