A randomised, double-blind, single-dose, active-controlled,
crossover study in healthy subjects to
demonstrate pharmacokinetic equivalence of
AltebrelTM (produced by AryoGen Pharmed) and Enbrel:registered:(produced by Amgen Company)
This is a single-dose trial with one administration of each product (AltebrelTM and Enbrel®). Each subject will participate in two treatment periods, and will be randomised to receive AltebrelTM or Enbrel® in a crossover fashion. The subjects will be hospitalized in the trial site for 24 hours after dosing for serial pharmacokinetic sampling. The subjects will be requested to visit the trial site 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 h after dose administration for blood sampling and evaluation of safety variable and tolerability.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016033021315N4
Registration date:2017-06-06, 1396/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
AryoGen Pharmed company
Expected recruitment start date
2016-12-04, 1395/09/14
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomised, double-blind, single-dose, active-controlled,
crossover study in healthy subjects to
demonstrate pharmacokinetic equivalence of
AltebrelTM (produced by AryoGen Pharmed) and Enbrel:registered:(produced by Amgen Company)
Public title
Comparison between AltebrelTM and Enbrel®
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
1)Provide written IC to participate in the trial and to comply with the trial procedures.
2)Take written informed consent to participate in the trial and to abide by the trial restrictions.
3)Be healthy male between the ages of 18 and 55 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
4)Have a body mass index between 20.0 and 30 kg/m², inclusive
5)Have Chest X-ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
Exclusion:
1.Being doubtful about their availability to complete the trial.
2.history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IMP formulation or comparable drugs.
3.Active or latent Tuberculosis or who have a history of Tuberculosis.
4.history of invasive systemic fungal infections or other opportunistic infections
5.systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
6.serious infection associated with hospitalisation and/or which required intravenous antibiotics
7.history of and/or current cardiac disease
8.Have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
9.Intake medication with a half-life > 24 h within 1 month or 5 half-lives of the medication prior to the first administration of IMP.
10.Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody. A positive test for HIV antibody.
11.History of CNS demyelinating disorders in family (MS)
12.Have a history of smoking >10 cigarettes per day