Relative bioavailability comparison of Alprazolam 0.5mg tablet in healthy adult male volunteers
Design
Double-Blind,Cross-over, two sequences, and two-period study and outcome assessment,
Twenty four subjects
A washout period of 7 days
Each subject was considered as his own control.
Settings and conduct
Blood sampling is done in the hospital.Volunteers and clinical caregivers are blind. The code of the volunteers,the intervention and control group is placed in an envelope by the researcher and is distributed randomly on the day of the experiment without informing the volunteer and the clinical caregiver.
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Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Gender: Male
Age:18 and 50 years
The volenteer is willing to do the study and can sign and submit the informed consent form
The candidate is fully present during the study
Normal clinical and laboratory results
Exclusion Criteria:
History of allergy or allergy to alprazolam
Any history of hypersensitivity or intolerance that, reduces the safety of the study volunteers
Any history of chronic infectious disease, systemic defects, or organ dysfunction
Gastrointestinal disease, malabsorption in the last year
A history of a medical problem over the last year that required medication or hospitalization
Drugs that significantly induce or inhibit drug-metabolizing enzymes that be used within 30 days prior to administration
Receive any medication from previous research studies within 30 days prior to the current study
Donation or loss of significant amounts of blood within 30 days prior to current study
Smokers or addicts
Intervention groups
Raha Pharmaceutical Company-Alprazolam 0.5mg tablet
Pfizer Pharmaceutical Company-Alprazolam 0.5mg tablet
Main outcome variables
Confirmation or non-confirmation of the bioequivalance of the sample and reference drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201212049683N1
Registration date:2021-01-03, 1399/10/14
Registration timing:prospective
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Akram Sharifian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7117
Email address
dash481@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations in healthy adult male volunteers under fasting conditions
Public title
Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: Male
Age between 18 and 50 years
The volenteer is willing to do the study and can sign and submit the informed consent form
The candidate is fully present during the study and according to the consent form, believes in and adheres to the implementation of the study protocol
Candidate must have a specific place of residence and a landline
Normal clinical and laboratory results
Exclusion criteria:
History of allergy or allergy to alprazolam
Any history of hypersensitivity or intolerance that, in the opinion of the researcher, reduces the safety of the study volunteers
Any history of chronic infectious disease, systemic defects, or organ dysfunction
Presence of gastrointestinal disease or a history of malabsorption in the last year
A history of a medical problem over the last year that required medication or hospitalization
Drugs that significantly induce or inhibit drug-metabolizing enzymes that be used within 30 days prior to administration
Receive any medication from previous research studies within 30 days prior to the current study
Donation or loss of significant amounts of blood (480 ml or more) within 30 days prior to current study
Smokers or addicts
Age
From 18 years old to 50 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done individually, using a sealed envelope. The code of the volunteers and the Test and Control group is placed in the envelope by the researcher and distributed randomly on the day of the experiment without the knowledge of the volunteer and the clinical caregiver.
Blinding (investigator's opinion)
Double blinded
Blinding description
Volunteers, project partners, physicians,nurses, and those responsible for the initial data collection and analysis of data, are only unaware of the date of receipt of the sample or reference drug. Volunteers code and and tha date of receipt of the sample or reference is determined by the researcher.
Volunteers, project partners, physicians , nurses, and those responsible for the initial data collection and analysis of data, are aware of the type of drug and its manufacturer.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.596
Health conditions studied
1
Description of health condition studied
Relative bioavailability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of Cmax, Tmax and AUC and comparison of blood profiles of the two drugs