BIOMAT Database Logo BIOMAT Database Logo

Bioequivalence of two oral formulations of clopidogrel tablets in healthy male volunteers. 2009

O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Egyptian International Pharmaceutical Industries Company, Cairo, Egypt.

A randomized, two-way, crossover, bioequivalence study in 32 fasting, healthy, male volunteers was conducted to compare two brands of clopidogrel 75 mg tablets, Thrombo (EIPICO, Egypt) as test and Plavix (Sanofi Pharma/Bristol-Myers Squibb, Paris, France) as reference. The study was performed in a Pharmaceutical Research Unit (PRU) using HPLC/ MS-MS. Arithmetic means for clopidogrel test versus reference formulation, respectively were for Cmax (4.39 +/- 2.58 vs. 4.30 +/- 2.65) ng/ml, AUC0-t (11.98 +/- 9.82 vs. 12.01 +/- 9.46) ng.h/ml, AUC0- yen (12.43 +/- 9.94 vs. 12.49 +/- 9.58) ng.h/ml, t1/2 (6.06 +/- 3.87 vs. 5.87 +/- 2.47) h and the medians for tmax (1 h vs. 0.75 h). Arithmetic means for clopidogrel carboxylic acid metabolite were Cmax (3.75 +/- 1.19 vs. 3.51 +/- 0.97) microg/ml AUC0-t (9.18 +/- 2.36 vs. 9.17 +/- 2.06) microg.h/ml, AUC0- yen (9.72 +/- 2.4 vs. 9.80 +/- 2.21) microg.h/ml , and t1/2 (6.43 +/- 3.52 vs. 6.33 +/- 1.71) h for test versus reference formulation respectively and there was no difference in the medians for tmax (0.75 h). The parametric 90% confidence intervals for the mean of the difference between log-transformed values were within the accepted range for bioequivalence of 80 - 125% as proposed by the US-FDA , namely for clopidogrel (90.66% - 109.66%), (90.63% - 109.73%), and (93.19% - 115.37%) for AUC0-t, AUC0- yen, and Cmax, respectively and also for clopidogrel carboxylic acid metabolite (94.90 - 104.19) , (94.04 - 103.86) and (96.47 - 114.79) for AUC0-t , AUC0- yen, and Cmax, respectively. Thus there was no significant difference between these values and therefore the two products can be considered bioequivalent.

UI MeSH Term Description Entries
D008297 Male Males
D010975 Platelet Aggregation Inhibitors Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. Antiaggregants, Platelet,Antiplatelet Agent,Antiplatelet Agents,Antiplatelet Drug,Blood Platelet Aggregation Inhibitor,Blood Platelet Antagonist,Blood Platelet Antiaggregant,PAR-1 Antagonists,Platelet Aggregation Inhibitor,Platelet Antagonist,Platelet Antagonists,Platelet Antiaggregant,Platelet Antiaggregants,Platelet Inhibitor,Protease-Activated Receptor-1 Antagonists,Antiplatelet Drugs,Blood Platelet Aggregation Inhibitors,Blood Platelet Antagonists,Blood Platelet Antiaggregants,Platelet Inhibitors,Agent, Antiplatelet,Aggregation Inhibitor, Platelet,Antagonist, Blood Platelet,Antagonist, Platelet,Antiaggregant, Blood Platelet,Antiaggregant, Platelet,Drug, Antiplatelet,Inhibitor, Platelet,Inhibitor, Platelet Aggregation,PAR 1 Antagonists,Platelet Antagonist, Blood,Platelet Antiaggregant, Blood,Protease Activated Receptor 1 Antagonists
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077144 Clopidogrel A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION. Clopidogrel Besilate,Clopidogrel Besylate,Clopidogrel Bisulfate,Clopidogrel Hydrochloride,Clopidogrel Napadisilate,Clopidogrel Sandoz,Clopidogrel, (+)(S)-isomer,Clopidogrel-Mepha,Iscover,PCR 4099,PCR-4099,Plavix,SC 25989C,SC 25990C,SR 25989,Clopidogrel Mepha
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D013988 Ticlopidine An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES. 53-32C,Ticlid,Ticlodix,Ticlodone,Ticlopidine Hydrochloride,53 32C,5332C,Hydrochloride, Ticlopidine

Related Publications

O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence of two oral formulations of nizatidine capsules in healthy male volunteers.
April 2005, Biopharmaceutics & drug disposition,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence study of two mirtazapine oral tablet formulations in healthy Chinese male volunteers.
May 2012, International journal of clinical pharmacology and therapeutics,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence study of two clopidogrel film-coated tablet formulations in healthy volunteers.
January 2011, Arzneimittel-Forschung,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence evaluation of two different formulations of ciprofloxacin tablets in healthy volunteers.
September 2007, Singapore medical journal,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers.
January 2004, Arzneimittel-Forschung,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence study of two generic formulations of 10 mg montelukast tablets in healthy Thai male volunteers.
September 2010, International journal of clinical pharmacology and therapeutics,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence of clopidogrel hydrogen sulfate tablets in healthy Chinese volunteers.
December 2015, Genetics and molecular research : GMR,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
A bioequivalence study of two omeprazole formulations in healthy male volunteers.
November 2016, International journal of clinical pharmacology and therapeutics,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence study of two oral formulations of cefadroxil in healthy volunteers.
January 2008, Arzneimittel-Forschung,
O El Ahmady, and M Ibrahim, and A M Hussein, and R T Bustami
Bioequivalence of two oral formulations of triflusal capsules in healthy volunteers.
January 2008, Arzneimittel-Forschung,
Copied contents to your clipboard!