Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects

• Published in: Drug design, development and therapy Vol. 8; no. default; pp. 1249 - 1255
• Main Authors: Tjandrawinata, Raymond, Setiawati, Effi, Putri, Ratih S.I., Yunaidi, Danang A., Amalia, Fawzia, Susanto, Liana W.
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2014; Taylor & Francis Ltd; Dove Press; Dove Medical Press
• Subjects: Adult; Amines - administration & dosage; Amines - pharmacokinetics; antiepilepsy; Bioavailability; bioequivalence; Clinical medicine; Confidence intervals; Convulsions & seizures; Cross-Over Studies; Cyclohexanecarboxylic Acids - administration & dosage; Cyclohexanecarboxylic Acids - pharmacokinetics; Dosage; Dosage and administration; Dose-Response Relationship, Drug; Drug dosages; FDA approval; Female; Food; Gabapentin; gamma-Aminobutyric Acid - administration & dosage; gamma-Aminobutyric Acid - pharmacokinetics; Headache; Healthy Volunteers; Hematology; Hepatitis; High performance liquid chromatography; HIV; Human immunodeficiency virus; Humans; International conferences; Laboratories; Liquid chromatography; Male; Middle Aged; Nausea; Original Research; Pharmacokinetics; Pharmacology; Phosphatase; Single-Blind Method; Statistical analysis; Statistical methods; Therapeutic Equivalency; Urine; Young Adult; Indonesia; Jakarta Indonesia; bioavailability; antiepilepsy; bioequivalence

The current study was conducted to find out whether two oral preparations of 300 mg gabapentin (the test and reference capsules) were bioequivalent. This was a randomized, single-blind, crossover study under fasting condition, with a 7-day washout period, which included 37 healthy adult male and fem...