Bioavailability and pharmacokinetics of norethisterone in women after oral doses of ethynodiol diacetate.
Contraception
; 19(2): 119-27, 1979 Feb.
Article
en En
| MEDLINE
| ID: mdl-428229
ABSTRACT
PIP: Bioavailability and pharmacokinetics of norethisterone (NE) were studied in 12 women, aged 21-37 years, after oral doses of ethynodiol diacetate (EDA). Plasma NE levels, measured by radioimmunoassay, were used to compare the bioavailability of EDA tablets (Ovulen 50; 1 mg EDA plus .05 mg ethinyl estradiol) with that of a standard oral solution of EDA. The 3 different batches of tablets studied showed different in vitro dissolution rates, 82.6%, 94.6%, and 99% at 3 hours. No marked differences were seen in the bioavailability of the tablet formulations, which were essentially bioequivalent to the solution. Peak plasma NE levels were reached within 4 hours of EDA administration in solution or tablets. Following the peak, NE plasma levels declined in 2 phases, with mean terminal elimination 1/2-lives of 4-6.9 hours. These results have shown that small variations in in vitro dissolution rates do not affect the bioavailability of NE from tablets containing EDA.
Palabras clave
Age Factors; Clinical Research; Contraception; Contraceptive Agents, Estrogen--administraction and dosage; Contraceptive Agents, Female--administraction and dosage; Contraceptive Agents, Progestin--administraction and dosage; Contraceptive Agents--administraction and dosage; Demographic Factors; Ethynodiol Diacetate--administraction and dosage; Examinations And Diagnoses; Family Planning; In Vitro; Laboratory Examinations And Diagnoses; Laboratory Procedures; Mestranol--administraction and dosage; Oral Contraceptives, Combined; Population; Population Characteristics; Research Methodology; Women
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Diacetato de Etinodiol
/
Noretindrona
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Female
/
Humans
Idioma:
En
Revista:
Contraception
Año:
1979
Tipo del documento:
Article
Pais de publicación:
Estados Unidos