Chulalongkorn University Theses and Dissertations (Chula ETD)

การศึกษาชีวสมมูลของยาคุมกำเนิดหลังร่วมเพศ (ลีโวนอร์เจสเตรล 0.75 มิลลิกรัม) สองชนิดในสตรีไทย

Other Title (Parallel Title in Other Language of ETD)

The bioequivalence study of two postcoital contraceptives (levonorgestrel 0.75 mg.) in Thai women

Year (A.D.)

2000

Document Type

Thesis

First Advisor

สุมนา ชมพูทวีป

Second Advisor

สมัย ลีพัฒน์ไพบูลย์

Faculty/College

Graduate School (บัณฑิตวิทยาลัย)

Degree Name

วิทยาศาสตรมหาบัณฑิต

Degree Level

ปริญญาโท

Degree Discipline

เภสัชวิทยา

DOI

10.58837/CHULA.THE.2000.1600

Other Abstract (Other language abstract of ETD)

The purpose of this study was to determine the bioequivalence of two postcoital contraceptives containing levonorgestrel 0.75 mg which were local and original product. The experiment was assigned to be randomized crossover design in 12 healthy Thai female volunteers who were given a single oral dose of levonorgestrel 0.75 mg (1 tablet) and blood samples were drawn at O, 1, 1.5, 2, 2.5 3, 3.5, 4, 6, 10 and 24 hrs after drug administration. The plasma drug concentration was determine by radioimmunoassay and analyzed for pharmacokinetic parameters of levonorgestrel. The results present that the peak plasma concentration (C[subscript max]), the time to peak plasma concentration (t[subscript max]) and area under the plasma concentration time curve (AUC) between two product were statistically difference (p<0.05). Difference of t[subscript max] equals 55.08% and the 90% Confidence interval for the difference of C[subscript max] and AUC means based on log transformed data of two products were within 9.24-124.29% and 65.13-105.67% respectively, referring, the two postcoital contraceptives were not bioequivalence.

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