Title
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fed Conditions
Phase
N/ALead Sponsor
Roxane LaboratoriesStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
MigraineIntervention/Treatment
naratriptan ...Study Participants
33The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fed conditions.
2.5 mg tablet
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.