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A randomized, open label, single dose, crossover, bioequivalence study of Dimethyl Fumarate 240mg capsule of Nanoalvand Co., IRAN in comparison of Tecfidera 240mg capsule of Biogen in 24 healthy adult subjects under fasting condition

Protocol summary

Study aim
A randomized, open label, single dose, crossover, bioequivalence study of Dimethyl Fumarate 240mg capsule of Nanoalvand Co., IRAN in comparison of Tecfidera 240mg capsule of Biogen in 24 healthy adult subjects under fasting condition
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 three
Intervention groups
Intervention: Dimethyl Fumarate 240mg capsule, produced by Nanoalvand Co., (IRAN), single dose. Control: Tecfidera one 240mg capsule, produced by Biogen company, single dose
Main outcome variables
Plasma concentration of Monomethyl Fumarate at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 & 10.0 hr. after dosing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190706044111N22
Registration date: 2021-07-03, 1400/04/12
Registration timing: prospective

Last update: 2021-07-03, 1400/04/12
Update count: 0
Registration date
2021-07-03, 1400/04/12
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
2021-07-23, 1400/05/01
Expected recruitment end date
2022-03-20, 1400/12/29
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 Dimethyl Fumarate 240mg capsule of Nanoalvand Co., IRAN in comparison of Tecfidera 240mg capsule of Biogen in 24 healthy adult subjects under fasting condition
Public title
Bioequivalence study of Dimethyl Fumarate 240mg capsule of Nanoalvand 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 Excel software, each subject will be randomly assigned to one of the two sequence AB or BA in a balanced manner
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
2021-06-21, 1400/03/31
Ethics committee reference number
IR.ZAUMS.REC.1400.106

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis

Primary outcomes

1

Description
Monomethyl Fumarate (MMF)
Timepoint
at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 & 10.0 hr. after dosing
Method of measurement
Using High Performance Liquid Chromatography wit MS detector (HPLC/MS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dimethyl Fumarate 240mg capsule, produced by Nanoalvand Co., (IRAN), single dose.
Category
Other

2

Description
Control group: Tecfidera one 240mg capsule, produced by Biogen company, single dose.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Core Research Lab. of ZAUMS
Full name of responsible person
Ghasemi Marzieh
Street address
Emam Ali Hospital, Salamat Blv., Khalij-e-Fars Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5664
Fax
+98 54 3329 5665
Email
crl@zaums.ac.ir
Web page address
http://crl.zaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nanoalvand Co.
Full name of responsible person
Nima Sepehri
Street address
Unit 52, No. 485 Seyed Jamalledin-e-AsadAbadi st.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8802 0579
Fax
+98 21 8802 0597
Email
info@nanoalvand.com
Web page address
https://fa.nanoalvand.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nanoalvand Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com

Person responsible for updating data

Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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