NCT02185846

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
Last Updated

July 10, 2014

Status Verified

May 1, 2014

Enrollment Period

Same day

First QC Date

July 6, 2014

Last Update Submit

July 9, 2014

Conditions

Healthy

Keywords

Fed condition

Outcome Measures

Primary Outcomes (2)

  • Cmax 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, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing.

  • 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, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing

Study Arms (2)

DYNABAC 250 MG ENTERIC COATED TABLET

ACTIVE COMPARATOR

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

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

Interventions

DYNABAC 250 MG ENTERIC COATED TABLETDRUG
DYNABAC 250 MG ENTERIC COATED TABLET
DIRITHROMYCIN 500 MG ENTERIC COATED TABLETDRUG
DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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 drugsor 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
  • Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug administration.
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Amman, 11941, Jordan

Location

MeSH Terms

Interventions

dirithromycinTablets, Enteric-Coated

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical PreparationsTablets

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

July 6, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-05

Locations

JO(1)