Bioequivalence study of four different trademarks of enalapril maleate in spontaneously hypertensive rats.
BACKGROUND
High blood pressure is a systemic disease which has major clinical and psycho-social repercussions, involves a high morbidity-mortality rate and generates high costs for the health system. Its treatment involves the use of antihypertensive drugs, which are commercialized as trademark, generic or similar drugs.


OBJECTIVE
To verify the antihypertensive effect produced by a similar dose of different trademarks of enalapril maleate in spontaneously hypertensive rats (SHR).


METHODS
Fifteen mg/kg of enalapril maleate were administered by gavage in 50 SHR rats and their blood pressure was verified through tail plethysmography every three days in a period of 16 days.


RESULTS
The group treated with reference drug has shown a significant reduction on blood pressure levels when compared to the control group. Thus, treatments with enalapril maleate of generic, similar-A and similar-B brands have also shown significant reduction on animals' blood pressure.


CONCLUSIONS
The use of generic drug and similars (A and B) drugs in the same doses and for the same period of time has not shown significant difference regarding the reference drug, which suggests that the brands tested are bioequivalent.
Baracho
Nilo César do Vale
NC
Pharmacology Department, Faculty of Medicine at Itajubá, Minas Gerais, Brazil.
Arruda
Guilherme D'Andréa Saba
GD
Alves
Lidinei José
LJ
Carneiro
Márcio Felipe Salomon
MF
Siqueira
Matheus Teodoro Grilo
MT
Arango
Héctor Gustavo
HG
Marcos dos Reis
José
J
D000818:Animals; D000959:Antihypertensive Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000627:therapeutic use; D004656:Enalapril / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000378:metabolism; D010991:Plethysmography; D051381:Rats; D011918:Rats, Inbred SHR; D013623:Tail; D013810:Therapeutic Equivalency
D000959:Antihypertensive Agents; D016568:Drugs, Generic; D004656:Enalapril