A randomized, open label, single dose, crossover, bioequivalence study of Fexofenadine 180mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN in comparison of Telfast 180mg tablet of Sanofi in 24 healthy adult subjects under fasting condition
A randomized, crossover bioequivalence study of single dose of test formulation (Fexofenadine 180mg tablet of Jaber Ebne Hayyan Pharm. Co.) in comparison of reference product (Telfast 180mg 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.
Design
A randomized, open label, single dose, crossover, bioequivalence study in 24 healthy subjects under fasting condition
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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;
Intervention groups
Intervention: Single dose of one Fexofenadine 180mg tsblet of Jaber Ebne Hayyan Pharm. Co, IRAN
Control: Single dose of one Telfast 180mg tablet of Sanofi
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190706044111N25
Registration date:2022-01-01, 1400/10/11
Registration timing:prospective
Last update:2022-01-01, 1400/10/11
Update count:1
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Ladan Tayebi
Name of organization / entity
Pars Biopharmacy Research Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6061
Email address
l.tayebi@parsbiopharmacy.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, open label, single dose, crossover, bioequivalence study of Fexofenadine 180mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN in comparison of Telfast 180mg tablet of Sanofi in 24 healthy adult subjects under fasting condition
Public title
Bioequivalence study of Fexofenadine 180mg tablet of Jaber Ebne Hayyan Pharm. Co., IRAN
Purpose
Other
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 50 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
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
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of medical Sciences
Street address
Dr. Hessabi square Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.ZAUMS.REC.1400.313
Health conditions studied
1
Description of health condition studied
allergic rhinitis
ICD-10 code
Z88.9
ICD-10 code description
Allergy status to unspecified drug/meds/biol subst