Protocol summary
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Study aim
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To characterize the rate and extent of bioavailability of test in comparison of reference product after single dose administration in healthy subjects under fasting condition. - To assess the bioequivalence of test formulation (Aristatin 10mg tablet of Arya Pharm Co., IRAN) with reference product (Crestor 10mg tablet of Astra-Zeneca ) by means of AUC0-t and Cmax . - Safety and tolerability evaluation of test product in comparison with reference in subjects
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Design
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A randomized, open label, two treatments, two periods, single dose, crossover, bioequivalence study of Aristatin 10mg tablet of Arya Pharm Co., IRAN in comparison of Crestor 10mg tablet of Astra-Zeneca in 24 healthy subjects under fasting condition
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Settings and conduct
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1- 24 healthy subjects enroll in this project. Volunteers provide written informed consent.
2- A single dose of 2*10 mg rosuvastatin will administer, in each study period. 3-The Blood samples collect before and at 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. post-dose.
4- The treatment phases separate by a washout period of at least 7 days.
5- Plasma samples will transfer to analytical Lab. to measure rosuvastatin in the plasma by means of HPLC.
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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 three months; History of drug or alcohol abuse ; Used any medication within 7- 14 days before the first treatment; History of allergic to statins
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Intervention groups
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Intervention: single dose of Aristatin 10mg tablet of Arya Pharm Co., IRAN Control: single dose of Crestor 10mg tablet of Astra-Zeneca
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Main outcome variables
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Plasma concentration of rosuvastatin
General information
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Reason for update
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This Study was cancelled by sponsor (Arya Pharm. Co.)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190706044111N8
Registration date:
2019-09-09, 1398/06/18
Registration timing:
prospective
Last update:
2022-01-10, 1400/10/20
Update count:
1
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Registration date
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2019-09-09, 1398/06/18
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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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2019-10-23, 1398/08/01
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Expected recruitment end date
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2020-05-20, 1399/02/31
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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, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Aristatin 10mg tablet of Arya Pharm Co., IRAN and Crestor 10mg tablet of Astra-Zeneca in 24 healthy adult subjects under fasting condition
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Public title
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Bioequivalence study of Aristatin 10mg tablet of Arya 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 showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment
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.
Subject had a history of allergic to statins
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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:
24
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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Not randomized
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Randomization description
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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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2018-11-04, 1397/08/13
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1397.624
Health conditions studied
1
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Description of health condition studied
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Hyperlipidemia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Plasma concentration of rosuvastatin
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Timepoint
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At 0 (before dosing), 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing
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Method of measurement
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HPLC
Intervention groups
1
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Description
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Intervention group: Intervention group: Single dose of Aristatin 10mg tablet of Arya Pharm Co., IRAN
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Category
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Other
2
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Description
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Control group: Single dose of Crestor 10mg tablet of Astra-Zeneca
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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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Arya Pharm Company
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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