Topics

A Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to assess the Bioequivalence between Two Formulations of Clonazepam Tablet in Healthy Subjects.

07:00 EST 8th November 2019 | BioPortfolio

Summary of "A Randomized, Single-dose, Two-sequence, Two-period, Crossover Study to assess the Bioequivalence between Two Formulations of Clonazepam Tablet in Healthy Subjects."

Clonazepam is a benzodiazepine commonly prescribed to treat panic disorder, epilepsy, anxiety, depression and certain types of seizures. This study aimed to evaluate the bioequivalence between two formulations of clonazepam tablets in order to meet regulatory requirements for marketing in Colombia and others countries in Latin America. An open-label, randomized, single-dose, two-period, two-sequence, two-treatment crossover study was conducted in 36 healthy subjects of both genders. Subjects received a single dose of clonazepam 2 mg test tablet (Sanofi-Aventis de Colombia S.A.) and reference product (Rivotril®, Produtos Roche Químicos e Farmacêuticos S.A.) under fasting conditions according to a randomly assigned order with a 21-day washout period. Serial blood samples were collected up to 96h post-dose. Plasma concentrations of clonazepam were obtained by a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated using non-compartmental methods. A total of 36 healthy subjects were enrolled and 31 of them completed the study. Twenty-nine adverse events were reported (11 events with test product 18 events with reference product). There were no serious adverse events during the study. Geometric mean ratios (90% confidence intervals) for C and AUC were 103.28% (98.10 - 108.64) and 102.50% (99.87 - 105.19), respectively. The test formulation of clonazepam 2 mg tablet manufactured by Sanofi-Aventis de Colombia S.A. was considered bioequivalent to reference product Rivotril (Produtos Roche Químicos e Farmacêuticos S.A.) according to regulatory requirements. Both formulations were safe and well tolerated during the study.

Affiliation

Journal Details

This article was published in the following journal.

Name: Drug development and industrial pharmacy
ISSN: 1520-5762
Pages: 1-18

Links

DeepDyve research library

PubMed Articles [37046 Associated PubMed Articles listed on BioPortfolio]

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

This was an open-label, phase I, nonrandomized, single-sequence, crossover study to evaluate the effect of concomitant administration of multiple doses of clarithromycin on the single-dose exposure, s...

Open-Label, Randomized, Single-Dose, 2-Period, 2-Sequence Crossover, Comparative Pharmacokinetic Study to Evaluate Bioequivalence of 2 Oral Formulations of Olanzapine Under Fasting and Fed Conditions.

Olanzapine, a second-generation atypical antipsychotic drug, is widely used for schizophrenia and moderate to severe mania associated with bipolar disorders. This open-label, randomized, single-dose, ...

Absolute Oral Bioavailability of Glasdegib (PF-04449913), a Smoothened Inhibitor, in Randomized Healthy Volunteers.

Glasdegib (PF-04449913) is an oral small-molecule inhibitor of the Hedgehog signaling pathway under development for treating myeloid malignancies. This was an open-label phase 1, randomized, 2-sequenc...

A single dose of purple grape juice improves physical performance and antioxidant activity in runners: a randomized, crossover, double-blind, placebo study.

To investigate the effects of a single dose of juice on physical performance, oxidative stress, inflammation and muscle damage in runners.

Canned food intake and urinary bisphenol a concentrations: a randomized crossover intervention study.

Bisphenol A (BPA) is an endocrine disruptor. To evaluate the effect of canned food consumption on internal BPA dose, urinary BPA concentrations were measured before and after intake of canned foods. T...

Clinical Trials [26984 Associated Clinical Trials listed on BioPortfolio]

HDDO-1614 Intervention Trial

Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a s...

PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

- Objective: - A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Tor...

A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose ...

Medical and Biotech [MESH] Definitions

Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.

Technique that utilizes low-stringency polymerase chain reaction (PCR) amplification with single primers of arbitrary sequence to generate strain-specific arrays of anonymous DNA fragments. RAPD technique may be used to determine taxonomic identity, assess kinship relationships, analyze mixed genome samples, and create specific probes.

Quick Search


DeepDyve research library

Relevant Topics

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Epilepsy
Epilepsy is defined as a disorder of brain function characterized by recurrent seizures that have a sudden onset.  (Oxford Medical Dictionary).  A seizure is caused by a sudden burst of excess electrical activity in the brain, causing a tempora...

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...


Searches Linking to this Article