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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
Single dose of 1.5 mg coated tablet
Single dose of 1.5 mg tablet
Unnamed facility
Morelia, Michoacán, Mexico
Least square estimator of average maximum plasmatic concentration (log transformed)
Time frame: After 2 months
Least square estimator of area under the pharmacokinetic curve (log transformed)
Time frame: After 2 months
Time at which maximum concentration is reached
Time frame: After 2 months
Area under the pharmacokinetic curve from time=0 to last blood sample
Time frame: After 2 months
Half life of plasmatic concentration of study drug
Time frame: After 2 months
Clearance constant of plasmatic concentration of study drug
Time frame: After 2 months
Adverse events collection
Time frame: Up to 8 weeks
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