Protocol summary
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Study aim
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A randomized, crossover bioequivalence study of single dose of test formulation (Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co.) in comparison of reference product (Telfast 120mg tablet ) by means of AUC0-t (Area Under the Curve up to the last measurable concentration) and Cmax (maximum plasma concentration) in healthy adult human subjects under fasting conditions.
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Design
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A randomized, open label, single dose, crossover, bioequivalence study in 24 healthy subjects under fasting condition
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Settings and conduct
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This study is carried out in Core Research Center of Zahedan University of Medical Sciences located in Imam Ali Hospital in Zahedan. There is a separate space for sampling and forecasting emergency situations in order to accommodate and rest the volunteers. This crossover and open label study was performed on 24 healthy volunteers. The volunteers' health is verified by the project physician prior to entry into the study, and the volunteers' status is regularly monitored by the project physician on the day of drug administration. This study will be covered by insurance in order to compensate for any adverse effects.
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Participants/Inclusion and exclusion criteria
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Main Inclusion criteria: Healthy subjects aged between 18 -50 years old and weighted between 50 – 100 kg\\ Main exclusion criteria: Clinically relevant deviations from normal; Donation a unit of blood or participated in another clinical trial within the last two months; History of drug or alcohol abuse; Used any medication within 7- 14 days before the first treatment;
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Intervention groups
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Intervention: Single dose of two Fexofenadine 120mg tablets of Jaber Ebne Hayyan Pharm. Co, IRAN
Control: Single dose of two Telfast 120mg tablets of Sanofi
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Main outcome variables
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Plasma concentration of Hydrochlorothiazide at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing
General information
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Reason for update
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Changing the drug dose from 180 mg tablet to 120 mg tablet
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190706044111N25
Registration date:
2022-01-01, 1400/10/11
Registration timing:
prospective
Last update:
2023-08-20, 1402/05/29
Update count:
1
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Registration date
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2022-01-01, 1400/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-21, 1400/11/01
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Expected recruitment end date
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2022-09-22, 1401/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A randomized, open label, single dose, crossover, bioequivalence study of Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN in comparison of Telfast 120mg tablet of Sanofi in 24 healthy adult subjects under fasting condition
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Public title
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Bioequivalence study of Fexofenadine 120mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
- Aged between 18 - 50 years
- Body weight between 50 – 100 kg
- Having good health on the basis of medical history and physical & clinical examination
- Understand the procedures and give written informed consent
Exclusion criteria:
Subject had undergone surgery of the gastro-intestinal tract treatment.
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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Bioequivalence
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Groups that have been masked
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No information
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Sample size
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Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
2
Each volunteer, 2 times take medicine in the study. One-time test product and the other time reference product with at least one week wash-out period
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using the rand command in Excel software, one of the sequences AB (test-reference product) or BA (reference-test product) is randomly assigned to each volunteer at random.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-12, 1400/09/21
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Ethics committee reference number
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IR.ZAUMS.REC.1400.313
Health conditions studied
1
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Description of health condition studied
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allergic rhinitis
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ICD-10 code
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Z88.9
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ICD-10 code description
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Allergy status to unspecified drug/meds/biol subst
Primary outcomes
1
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Description
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Plasma concentration of fexofenadine
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Timepoint
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at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing
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Method of measurement
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High Performance Liquid Chromatography (HPLC)
Intervention groups
1
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Description
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Intervention group: two 120mg Fexofenadine tablets, produced by Jaber Ebne Hayyan Pharm. Co. (IRAN), single dose.
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Category
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Other
2
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Description
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Control group: Telfast, two 120mg tablets, produced by Sanofi company, single dose.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Jaber Ebne Hayyan Pharm. Co..
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available