Cross-over study to prove bioequivalence between two oral formulations of levonorgestrel 1.5 mg (LEVEQ-3)
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
- Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.
- History of illnesses or any organic abnormalities that could affect the results of the study. - History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs. - Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
Clinica de Enfermedades Cronicas y Procedimientos Especiales
Morelia, Mexico, 58256
E-mail: [email protected]
Phone: Not Available
Open-label, randomized, crossover study to prove the bioequivalence between Opxion® (levonorgestrel 1.5 mg coated tablet from Bayer de Mexico) and Postinor 2® (levonorgestrel 1.5 mg tablet from Biofarma Natural CMD) in healthy volunteers