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Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers.
Arzneimittelforschung. 2001; 51(12):955-8.A

Abstract

The aim of this study was to assess the pharmacokinetic profile of two bromazepam (CAS 1812-30-2) formulations in 24 healthy volunteers. An open, randomised clinical trial designed as two-period crossover with 14-day washout between doses was employed. Plasma samples for assessments of their bromazepam concentration by HPLC-UV were obtained over 96 h after administration. No adverse effect was reported for any of the formulations administered. The following pharmacokinetics parameters were calculated: AUC(0-96 h), AUCinf, Cmax, Tmax, Ke and T1/2. The 90% confidence intervals (CI) for the mean test/reference individual ratios were 81-109 for AUC and 84-116 for Cmax. Since the 90% CI for both, AUC and Cmax ratios were within the 80-125% interval proposed by the Food and Drug Administration, it is concluded that the new bromazepam slow-release formulation is therapeutic equivalent to the conventional formulation for both, the extent and the rate of absorption after single dose administration in healthy volunteers.

Authors+Show Affiliations

ClinPhaseOne Group, EDyABE (Estudios de Diseño y Análisis BioEstadísticos), Contract Research Organisation, Buenos Aires, Argentina.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11799841

Citation

Lerner, F E., et al. "Comparative Bioavailability of Two Oral Formulations of Bromazepam in Healthy Volunteers." Arzneimittel-Forschung, vol. 51, no. 12, 2001, pp. 955-8.
Lerner FE, Schere D, Batafarano N, et al. Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers. Arzneimittelforschung. 2001;51(12):955-8.
Lerner, F. E., Schere, D., Batafarano, N., Casas, F., & Glancszpigel, R. (2001). Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers. Arzneimittel-Forschung, 51(12), 955-8.
Lerner FE, et al. Comparative Bioavailability of Two Oral Formulations of Bromazepam in Healthy Volunteers. Arzneimittelforschung. 2001;51(12):955-8. PubMed PMID: 11799841.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers. AU - Lerner,F E, AU - Schere,D, AU - Batafarano,N, AU - Casas,F, AU - Glancszpigel,R, PY - 2002/1/22/pubmed PY - 2002/2/15/medline PY - 2002/1/22/entrez SP - 955 EP - 8 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 51 IS - 12 N2 - The aim of this study was to assess the pharmacokinetic profile of two bromazepam (CAS 1812-30-2) formulations in 24 healthy volunteers. An open, randomised clinical trial designed as two-period crossover with 14-day washout between doses was employed. Plasma samples for assessments of their bromazepam concentration by HPLC-UV were obtained over 96 h after administration. No adverse effect was reported for any of the formulations administered. The following pharmacokinetics parameters were calculated: AUC(0-96 h), AUCinf, Cmax, Tmax, Ke and T1/2. The 90% confidence intervals (CI) for the mean test/reference individual ratios were 81-109 for AUC and 84-116 for Cmax. Since the 90% CI for both, AUC and Cmax ratios were within the 80-125% interval proposed by the Food and Drug Administration, it is concluded that the new bromazepam slow-release formulation is therapeutic equivalent to the conventional formulation for both, the extent and the rate of absorption after single dose administration in healthy volunteers. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/11799841/Comparative_bioavailability_of_two_oral_formulations_of_bromazepam_in_healthy_volunteers_ L2 - https://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1300144 DB - PRIME DP - Unbound Medicine ER -