China
Africa
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Hard Shell Capsules in Clinical Trials
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Moji Christianah Adeyeye, Amusa Adebayo
In a randomized two-way crossover study that compared mifepristone in capsules with tablets in nonpregnant women, the authors reported that there was no significant difference in the major pharmacokinetic parameters, and the relative bioavailability was 109.4% ± 34.8% [134]. Another group of investigators compared the pharmacokinetic properties and bioequivalence of the capsule (test) and tablet (reference) formulations of meclofenoxate hydrochloride 200 mg in healthy Chinese volunteers [135]. They reported that the 90% CIs with and without log-transformed ratios of chlorophenoxyacetic acid (the active and detectable metabolite) were between 80% and 125%, in agreement with the FDA specifications.
The unapproved drug centrophenoxine (meclofenoxate) in cognitive enhancement dietary supplements
Published in Clinical Toxicology, 2022
Pieter A. Cohen, Bharathi Avula, Ikhlas Khan
Centrophenoxine (meclofenoxate, Figure 1) is prescribed in China and elsewhere to treat a variety of conditions including ethanol toxicity, dementia, and brain trauma [5]. The drug affects choline and other neurotransmitter levels in rat brains [6,7], but clinical evidence from human trials is limited due to the trials’ methodological weaknesses, small sample sizes with the largest study including 76 subjects, and discordant results [8–10]. Whether the drug has significant effects on human cognition remains unknown, and the US Food and Drug Administration (FDA) has not approved the drug for any indication. We designed our study to determine the presence and quantity of centrophenoxine in over-the-counter dietary supplements available in the US.
Cholinergic Medication for Antipsychotic‐Induced Tardive Dyskinesia
Published in Issues in Mental Health Nursing, 2019
Fourteen RCTs were included with a total of 364 participants; these were mostly conducted within hospital settings in the USA (2 studies recruited outpatients and one study was undertaken in each of the following countries: Japan, Canada, Australia, Iran, Switzerland and Germany). All studies compared a cholinergic drug against a placebo for the following treatments while the participants remained on their antipsychotic medication: n = 6 trials used Deanol, n = 4 Lecithin and n = 1 trial was found for each of the following: Meclofenoxate hydrochloride, Galantamine, Rivastigmine, Donepezil. For results please see Table 1.