Human Clinical

As a result of pharmaceutical companies tend to produce semi-synthetic and synthetic drugs and since previous centuries mid term also by discovery, production and supplying new drugs, some serious problems and side effects were emerged consequently, comprehensive regulations were issued to commit studies on animals as well as humans in advance to launch new drugs into the market. Usually clinical trials on humans to discover or confirm clinical effects, and pharmacology (pharmacodinamice & pharmacokinetic) or side effects are done and 4 Phases are included: Phase I: Researchers test an experimental drug or treatment in a small group of people (20-80) for first time to evaluate its safety, determine an appropriate dosage, trace what happens to the compound in the body, and begin to identify side effects. Phase II: The drug or treatment being studies is given to a larger group of people with the disease (100-300) to obtain preliminary evidence of an effect and to further evaluate its safety. If there is evidence of an effect and the risks are considered acceptable, the drug may move to the next stage. Phase III: This phase of trial tests a drug candidate in a larger number of people with the disease (at lest 1000), further testing its effectiveness and monitoring for side effects, in some cases this will be compared to a treatment standard, if one is already available. Phase IV: After a drug or treatment has been approved by the appropriate government and regulatory agencies and is being marketed, The company may study its safety and effectiveness over a longer period of time and in a larger number of people (this phase also are known as post-marketing studies). The company may also continue to study some of our marketed products for new indications. Thousands of people usually participate in phase IV trials and this phase exists until the product is used in the market and its effects will be recorded in the drug master file. Also in Iran, by expanding pharmaceutical companies and entering into the industry in various areas of drug, the necessity clinical trials commitment has been felt more than ever to prove the effectiveness and efficiency of drug and lack of side effects . Of course, almost all pharmaceutical companies’ products in Iran are generic and those previously have been subject to extensive clinical trials by the main manufacturers so there is no need to study. However, some companies assumed themselves to investigate some pharmaceutical drugs which Aburaihan pharmaceutical Co. is the leading among them. The studies done by this Co. usually have been defined to be proven on efficacy and lack of side effects by its own self or in comparison with imported similar drug. These studies are similar to standard clinical trials third phase. However, in some special cases also the usage of a new drug has been studied. It should be noted that all studies by Aburaihan pharmaceutical Co. reputable academic centers and approved by these centers´ are done by ethics committee. The Aburaihan pharmaceutical Co. is interested cooperating with drug companies, research centers, universities, medical students and residents group; to carry out studies on its own drugs

 

 

 

 
Studies subject
step study results
1 The comparison between the efficacy and incubation conditions obtained by Atracurium is produced by Aburaihan pharmaceutical Co. and imported Atracurium (made by GSK Co.) after induction of general anesthesia with Isoflurane in 80 experimented patients in Shariati Hospital, Tehran. Is finished                                              Click here 
2  The comparison between the efficacy of new Atracurium is produced by Aburaihan pharmaceutical Co. entitled as trade name (Anecur 50) and imported Atracurium (made by GSK Co.) in 30 experimented patients in the hospital Labbafinejad, Tehran Is finished Click here  
3 Investigation on Granisetron effects produced by Aburaihan pharmaceutical Co. (Gratril) on nausea and vomiting after eye surgery compared with standard drugs (kytril) and Metoclopramide in 150 sample people in Baghiyatallah Hospital.  Is finished Click here  
4 Evaluation of the efficacy of vaginal progesterone suppository in preventing preterm labour in women with symptoms of preterm labour in 228 patients in Al-Zahra Hospital, Rasht.  Is finished  Click here  
5 Short-term clinical experience of a new oral contraceptive (Marvelon) on quality of life and satisfaction among 61 Iranian women referred to family control planning clinics of Vliasr Fertility Health Research Center, Imam Hospital, Tehran.  Is finished  Click here  
6 Investigation on effect of 0.03% Tacrolimus ointment made by Aburaihan pharmaceutical Co. compared with placebo, in 60 atopic dermatitis patients, referred to dermatology clinic of Imam Hospital, Tehran  Is finished  Click here  
7 The Comparison between efficacy and side effects of Venustat (Orlistat made by Aburaihan pharmaceutical Co.) and Xenical (Orlistat made by Roch Co.) in 50 obese Iranian patients, referred to private clinic Tehran University of Medical Sciences, Endocrine Research Center.  Is finished  Click here  
8 The Comparison between Buserelin injections produced by Aburaihan pharmaceutical Co.  and Suprefact in pituitary desensitization in cycle IVF / ICSI in 49 patients in Tehran Royan institute.  Is finished  Click here  
9 The comparative study the effect of Tizanidine hydrochloride produced by Aburaihan pharmaceutical Co. and placebo on muscle cramps in 40 hemodialysis patients in dialysis centers in Isfahan.  In progress  Click here  
10 Compare the use of Enoxaparin alone with combination therapy of prednisone aspirin, progesterone in treatment of women with idiopathic recurrent miscarriage (IRM) in terms of live births and pregnancy outcome in 150 cases of Mazandaran Medical Sciences University, Imam Khomeini Hospital.  In progress  Click here  
11 - Survey and Comparison of Granisetron produced by Aburaihan pharmaceutical Co. (Gratril) and kytril and Metoclopramide in control of nausea and vomiting after surgeries Hysterectomy, Myomectomy and Wertheim in 150 candidate’s patients in Shariati Hospital, Tehran.  In progress  Click here  
12  - Comparison of intubation facility between two methods: cisatracurium and Remifentanil with cisatracurium usage of two types of cisatracurium (made by Aburaihan pharmaceutical Co. with Nimbex made by Abbott Co.) in 500 patients in Aneasthesiology Research Center of Iran.  Contract  Click here  
13 Investigation on clinical trials Psoriament (Calcipotriol) cream produced by Aburaihan pharmaceutical Co. in 15 healthy volunteers in skin products clinical evaluation unit of Tehran Medical University. Contract  Click here  
14  Survey and Comparison efficacy of Granisetron produced by Aburaihan pharmaceutical Co. (Gratril) and Promethazine in the control of Hyperemesis gravidarum in 120 patients in Shariati Hospital, Tehran Medical University. Study  Click here