Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions

NCT02237768 | Completed Phase 1

• 1 other identifier: DIRI520/PR-00
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.

Conditions

Healthy

Keywords

Fasting conditions

Outcome Measures

Primary Outcomes (2)

• Cmax Ratio

  Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the reference variance of σw2 within subject variability for the reference for Erythromycylamine

  pre-dosing and at 1.00, 1.25, 1.50, 1.75, 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, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours

• AUC Ratio

  The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00%based on Erythromycylamine.

  pre-dosing and at 1.00, 1.25, 1.50, 1.75, 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, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours

Study Arms (2)

DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

EXPERIMENTAL

DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once

Drug: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

DYNABAC 250 MG ENTERIC COATED TABLET

EXPERIMENTAL

DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once

Drug: DYNABAC 250 MG ENTERIC COATED TABLET

Interventions

DIRITHROMYCIN 500 MG ENTERIC COATED TABLET DRUG

DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

DYNABAC 250 MG ENTERIC COATED TABLET DRUG

DYNABAC 250 MG ENTERIC COATED TABLET

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmaceutical Research Unit, Jordan: lead
• Abdi Ibrahim Ilac San. ve Tic A.S.: collaborator

Study Sites (1)

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Amman, 11941, Jordan

Location

MeSH Terms

Interventions

dirithromycin; Tablets, Enteric-Coated

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Tablets

Study Officials

• Rana T Bustami, Phd.pharmacy

  PRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

JO (1)