Jadhav R
India
Research Article
Bioequivalence of Two Different Rivastigmine Hard Capsule Formulations
of Two Different Strengths (1.5 mg and 6 mg) in Indian Healthy Human
Adult Male Volunteers
Author(s): Garg M, Naidu R, Iyer K and Jadhav RGarg M, Naidu R, Iyer K and Jadhav R
Rivastigmine, a butyl- and acetylcholinesterase inhibitor, is approved for symptomatic treatment of Alzheimer's disease (AD). The aim of these studies was to determine the bioequivalence of test and reference formulations of Rivastigmine 1.5 mg and 6 mg Hard Capsule. Both studies were single dose, randomized, 2-period, 2-sequence, laboratory-blinded, crossover design. Rivastigmine 1.5 mg Hard Capsule study was conducted in 36 healthy adult Indian male volunteers under fasting conditions with a washout period of 5 days and Rivastigmine 6 mg Hard Capsule study was conducted in 40 healthy adult Indian male volunteers under fed conditions with a washout period of 7 days. For 1.5 mg study, blood samples for pharmacokinetic profiling were taken post-dose up to 10 h. For 6 mg study, blood samples for pharmacokinetic profiling were taken post-dose up to 12 h. Safe.. View More»
DOI:
10.4172/jbb.1000317