BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer OcakABSTRACT
Material and Method: 36 subjects were randomly assigned into two groups according to a computer-generated randomization scheme. The subjects in group 1 received the reference formulations in period 1 and the test formulation in period 2, and those in group 2 vice versa, with a 21-day washout period between periods 1 and 2. Totally 23 blood sample points were selected including predose. The determination of amlodipine, irbesartan and HCTZ were performed using a validated high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) in lithium heparinised human plasma.
Results: Pharmacokinetic findings showed that the newly developed FDC tablet of Nobel was bioequivalent to the marketed innovator formulations in healthy population under the studied conditions.
Conclusion: Results indicated that the new FDC formulation of Nobel can be used interchangeably with the conventional formulations of the innovators.
RISK FACTORS IN VICTIMS OF SEXUAL ASSAULTS WHO ACQUAINTED, AND MET WITH THEIR PERPETRATORS VIA SOCIAL NETWORKING SERVICES
05-11Bora Büken, Zerrin Erkol, Ferhan Kandemir, Erhan Büken
RESEARCH ARTICLE Nobel Med 2014; 10(3): 5-11STUDYING THE RELEVANCE OF SOME FACTORS THAT INFLUENCE THE QUALITY OF LIFE IN RHEUMATOID ARTHRITIS PATIENTS
12-17Andreea Silvana Szalontay, Corina Dima-Cozma, Petru Ifteni, Manuela Paraschiv, Diana-Sinziana Duca, Manuela Padurariu, Elena Rezuş
RESEARCH ARTICLE Nobel Med 2014; 10(3): 12-17BRUCELLOSIS: A RETROSPECTIVE EVALUATION OF 523 BRUCELLOSIS CASES FROM WESTERN ANATOLIA, TURKEY
18-23Nesrin Türker, Bahar Örmen, Nurbanu Sezak, Sevinç Arslan, Hülya Ellidokuz, Figen Kaptan, Sibel El, Serap Ural, İlknur Vardar
RESEARCH ARTICLE Nobel Med 2014; 10(3): 18-23BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY
24-31Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak
RESEARCH ARTICLE Nobel Med 2014; 10(3): 24-31THE RELATIONSHIP BETWEEN HELICOBACTER PYLORI INFECTION AND GLYCEMIC REGULATION IN TYPE 2 DIABETIC PATIENTS
32-35Seydahmet Akın, Muhammet Emin Erdem, Sinan Kazan, Mehmet Aliustaoğlu
RESEARCH ARTICLE Nobel Med 2014; 10(3): 32-35EVALUATION OF PANDEMIC INFLUENZA A (H1N1) CASES IN VAN REGION
36-40Aytekin Çıkman, Mustafa Berktaş, Mehmet Parlak, Yasemin Bayram, Görkem Yaman
RESEARCH ARTICLE Nobel Med 2014; 10(3): 36-40HIRSUTISM IN WOMEN OF REPRODUCTIVE AGE: ETIOLOGICAL FACTORS, CLINICAL SIGNS, AND HORMONAL PROFILE
41-47Filiz Cebeci, Nahide Onsun, Ayşe Pekdemir Şen, Ayşe Cinkaya, Sermet Akar
RESEARCH ARTICLE Nobel Med 2014; 10(3): 41-47EFFECTS OF PHOTOTHERAPY ON SERUM PARAOXONASE ACTIVITY AND TOTAL ANTIOXIDANT CAPACITY IN NEWBORN JAUNDICE
48-51Sevil Kurban, Ali Annagür, Hüseyin Altunhan, İdris Mehmetoğlu, Rahmi Örs, Said Sami Erdem, Fatma Hümeyra Yerlikaya, Aysun Toker, Erkan Taşyürek
RESEARCH ARTICLE Nobel Med 2014; 10(3): 48-51PSÖRİATİK ARTRİT HASTALARINDA YAŞAM KALİTESİNİN, HASTALIK AKTİVİTESİ VE TANISAL GECİKME SÜRESİ İLE İLİŞKİSİNİN DEĞERLENDİRİLMESİ
52-57Ferhat Gökmen, Murat Karkucak, Arzu Çapkın, Adem Karaca, Ayşegül Küçükali Türkyılmaz, Erhan Çapkın, Ayla Akbal
RESEARCH ARTICLE Nobel Med 2014; 10(3): 52-57THE COURSE AND BRANCHING PATTERN OF THE MEDIAN NERVE IN THE FOREARM
58-62Feray Güleç, Gülgün Şengül
RESEARCH ARTICLE Nobel Med 2014; 10(3): 58-62COMPARISON OF HOUNSFIELD UNITS OF THE RENAL PAPILLAE IN KIDNEY STONE FORMERS AND NON STONE FORMERS
63-68Orhun Sinanoğlu, Sinan Ekici, Basri Çakıroğlu, Rahmi Çubuk, Süleyman Hilmi Aksoy
RESEARCH ARTICLE Nobel Med 2014; 10(3): 63-68THE RELATIONSHIP OF VITAMIN D LEVELS WITH EARLY MORTALITY IN PATIENTS WITH ACUTE CORONARY SYNDROME AND VALUE OF VITAMIN D LEVELS AS A CARDIOVASCULAR RISK FACTOR
69-74Kadem Arslan, Murat Köse, Samim Emet, Timur Selçuk Akpınar, Şengül Aydın, Bahtiyar Toz, Yücel Arman, Tufan Tükek
RESEARCH ARTICLE Nobel Med 2014; 10(3): 69-74PLASMA TOTAL HOMOCYSTEINE, LIPOPROTEIN (A) AND VON WILLEBRAND FACTOR LEVELS IN ASSESSMENT OF METABOLIC CONTROLS OF CHILDREN WITH TYPE I DIABETES MELLITUS
75-80Sabahattin Ertuğrul, Yaşar Şen, Erdal Yılmaz, Mustafa Aydın, Bilal Üstündağ
RESEARCH ARTICLE Nobel Med 2014; 10(3): 75-80TOLERABILITY OF NIMESULIDE IN PATIENTS WITH HISTORIES OF ADVERSE REACTIONS TO ACETYLSALICYLIC ACID AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
81-87Fatma Merve Tepetam, Bahattin Çolakoğlu, Faruk Özer, Emin Maden, Şebnem Yosunkaya, Dildar Duman
RESEARCH ARTICLE Nobel Med 2014; 10(3): 81-87A POST-TRAUMATIC GIANT SUBLINGUAL RANULA
88-91Betül Taş, Özgür Pilancı, Mehmet Sar
REPORT Nobel Med 2014; 10(3): 88-91POSTTRAUMATIC PUNCTATE DIGITAL CALCINOSIS CUTIS CIRCUMSCRIPTA
92-96Betül Taş, Dilek Bıyık Özkaya, Banu Taşkın, Mehmet Öncü, Mehmet Sar
REPORT Nobel Med 2014; 10(3): 92-96PROF. DR. İRFAN TİTİZ (1903-1969)
97-100Çağatay Üstün, Nuray Demirci
A PORTRAIT Nobel Med 2014; 10(3): 97-100LIVER AND SYSTEMIC DISEASES
05-09Sebati Özdemir
REVIEW Nobel Med 2013; 9(2): 5-9AGING KIDNEY: SENESCENCE OR DISEASE?
10-14Meltem Gürsu, Rümeyza Kazancıoğlu, Savaş Öztürk
REVIEW Nobel Med 2013; 9(2): 10-14IMPORTANCE OF HOLOTRANSCOBALAMIN (HOLOTC) MEASUREMENTS IN EARLY DIAGNOSIS OF COBALAMIN DEFICIENCY, ESPECIALLY IN PATIENTS WITH BORDERLINE VITAMIN B12 CONCENTRATIONS
15-20Faruk Sönmezışık, Esma Sürmen Gür, Burak Asıltaş
RESEARCH ARTICLE Nobel Med 2013; 9(2): 15-20EVALUATION OF PHYSICAL GROWTH IN PATIENTS WITH FAMILIAL MEDITERRANEAN FEVER
21-25Celalettin Koşan, Oğuzhan Sepetçigil, Atilla Çayır, Avni Kaya, Behzat Özkan
RESEARCH ARTICLE Nobel Med 2013; 9(2): 21-25COMPARISON OF RISK INDEXES USED IN DETERMINING THE POSTOPERATIVE RESPIRATORY INSUFFICIENCY RISK
26-31Gülsüm Kavalcı, Cavidan Arar, Alkın Çolak, Nesrin Turan, Cemil Kavalcı
RESEARCH ARTICLE Nobel Med 2013; 9(2): 26-31THE EVALUATION OF PRENATAL AND ENVIROMENTAL RISK FACTORS IN CHILDREN WITH ASTHMA, ALLERGIC RHINITIS AND BRONCHIAL ASTHMA ABSTRACT
32-37Mehmet İbrahim Turan, Müferet Ergüven, Mehmet Özdemir
RESEARCH ARTICLE Nobel Med 2013; 9(2): 32-37REOPERATIONS AND MORBIDITY IN THYROID SURGERY
38-42Serkan Teksöz, Murat Özcan, Aytül Sargan, Yusuf Bukey, Recep Özgültekin, Ateş Özyeğin
RESEARCH ARTICLE Nobel Med 2013; 9(2): 38-42EFFECTS OF RAMADAN FASTING ON BLOOD PRESSURE CONTROL, LIPID PROFILE, BRAIN NATRIURETIC PEPTIDE, RENAL FUNCTIONS AND ELECTROLYTE LEVELS IN HYPERTENSIVE PATIENTS TAKING COMBINATION THERAPY
43-46İbrahim Faruk Aktürk, İsmail Bıyık, Cüneyt Koşaş, Ahmet Arif Yalçın, Mehmet Ertürk, Fatih Uzun
RESEARCH ARTICLE Nobel Med 2013; 9(2): 43-46MANAGEMENT OF A LARGE OUTBREAK CAUSED BY NOROVIRUS AND CAMPYLOBACTER JEJUNI OCCURRED IN A RURAL AREA IN TURKEY
47-51İbak Gönen
RESEARCH ARTICLE Nobel Med 2013; 9(2): 47-51FREQUENT CD99 AND FLI-1 EXPRESSIONS IN DIFFUSE LARGE B-CELL LYMPHOMA AND THEIR ASSOCIATION WITH PROLIFERATIVE AND APOPTOTIC RATES
52-56Ufuk Berber, İsmail Yılmaz, Tolga Tuncel, Zafer Küçükodacı Aptullah Haholu
RESEARCH ARTICLE Nobel Med 2013; 9(2): 52-56-
Pubmed Style
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak. [BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY]. Nobel Med 2014; 10(3): 24-31, English. -
Web Style
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak. [BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY]. www.nobelmedicus.com/en/Article.aspx?m=1716 [Access: Mayıs 24, 2021], English. -
AMA (American Medical Association) Style
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak. [BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY]. Nobel Med 2014; 10(3): 24-31, English. -
Vancouver/ICMJE Style
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak. [BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY]. Nobel Med (2014); 10(3): 24-31, [cited Mayıs 24, 2021], English. -
Harvard Style
Abdullah Uslu, İlksen Dikmen, Mustafa Köktürk, Serdar Ünlü, Seda Ünsalan, İclal Çakıcı, Sami Eren, Berrak Kılınç, Onursal Sağlam, Muradiye Nacak, Ömer Ocak. (2014) [BIOEQUIVALENCE STUDY OF A FIXED DOSE COMBINATION OF IRBESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE FILM COATED TABLET MANUFACTURED IN TURKEY]. Nobel Med, 10(3): 24-31, English.