Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations

Lona Louring Christrup; J Bonde; S N Rasmussen; J M Sonnergaard; B H Jensen

Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations

Lona Louring Christrup, J Bonde, S N Rasmussen, J M Sonnergaard, B H Jensen

3 Citations (Scopus)

Abstract

Single-dose and steady state pharmacokinetics of diltiazem administered in two different oral formulations were assessed with particular reference to rate and extent of absorption. Following single dose administration a significant difference in tmax was observed (2.9 +/- 1.9 and 6.8 +/- 2.6 hr respectively) whereas differences in AUC, t1/2 and Cmax were not significant. The AUC (mean +/- S.D.) values following single dose administration of Cardil and Cardizem were 678.4 +/- 321.5 and 948.6 +/- 580.6 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.89 and 0.44-1.34 respectively. At steady-state a significant difference between Cmax/Cmin and tmax was seen Cmax/Cmin being 4.9 and 3.2 respectively and Tmax being 2.7 +/- 2.0 and 6.0 +/- 2.8 hr respectively, whereas Cmax and AUC did not differ significantly. The AUC (mean +/- S.D.) values in steady state of Cardil and Cardizem were 880.1 +/- 399.8 and 1056.8 +/- 509.8 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.96 and 0.66-1.26 respectively. Although the observed ratios AUCCardil/AUCCardizem in both the single-dose and the steady-state study do not differ significantly from 1.0, the confidence limits exceed the acceptable values given by Poulsen & Juul (personal communication 1990) (a 20% decrease or increase of the ratio to 0.8 or 1.2).

Original language	English
Journal	Pharmacology & Toxicology
Volume	71
Issue number	4
Pages (from-to)	305-7
Number of pages	3
ISSN	0901-9928
Publication status	Published - Oct 1992

Keywords

Absorption
Administration, Oral
Adult
Biological Availability
Chromatography, High Pressure Liquid
Delayed-Action Preparations
Diltiazem
Female
Humans
Male
Tablets

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Christrup, L. L., Bonde, J., Rasmussen, S. N., Sonnergaard, J. M., & Jensen, B. H. (1992). Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations. Pharmacology & Toxicology, 71(4), 305-7. http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0773.1992.tb00989.x/abstract?systemMessage=Wiley+Online+Library+will+be+unavailable+on+Saturday+17th+December+2016+at+09%3A00+GMT%2F+04%3A00+EST%2F+17%3A00+SGT+for+4hrs+due+to+essential+maintenance.Apologies+for+the+inconvenience

Christrup, LL, Bonde, J, Rasmussen, SN, Sonnergaard, JM & Jensen, BH 1992, 'Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations', Pharmacology & Toxicology, vol. 71, no. 4, pp. 305-7. <http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0773.1992.tb00989.x/abstract?systemMessage=Wiley+Online+Library+will+be+unavailable+on+Saturday+17th+December+2016+at+09%3A00+GMT%2F+04%3A00+EST%2F+17%3A00+SGT+for+4hrs+due+to+essential+maintenance.Apologies+for+the+inconvenience>

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title = "Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations",

abstract = "Single-dose and steady state pharmacokinetics of diltiazem administered in two different oral formulations were assessed with particular reference to rate and extent of absorption. Following single dose administration a significant difference in tmax was observed (2.9 +/- 1.9 and 6.8 +/- 2.6 hr respectively) whereas differences in AUC, t1/2 and Cmax were not significant. The AUC (mean +/- S.D.) values following single dose administration of Cardil and Cardizem were 678.4 +/- 321.5 and 948.6 +/- 580.6 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.89 and 0.44-1.34 respectively. At steady-state a significant difference between Cmax/Cmin and tmax was seen Cmax/Cmin being 4.9 and 3.2 respectively and Tmax being 2.7 +/- 2.0 and 6.0 +/- 2.8 hr respectively, whereas Cmax and AUC did not differ significantly. The AUC (mean +/- S.D.) values in steady state of Cardil and Cardizem were 880.1 +/- 399.8 and 1056.8 +/- 509.8 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.96 and 0.66-1.26 respectively. Although the observed ratios AUCCardil/AUCCardizem in both the single-dose and the steady-state study do not differ significantly from 1.0, the confidence limits exceed the acceptable values given by Poulsen & Juul (personal communication 1990) (a 20% decrease or increase of the ratio to 0.8 or 1.2).",

keywords = "Absorption, Administration, Oral, Adult, Biological Availability, Chromatography, High Pressure Liquid, Delayed-Action Preparations, Diltiazem, Female, Humans, Male, Tablets",

author = "Christrup, {Lona Louring} and J Bonde and Rasmussen, {S N} and Sonnergaard, {J M} and Jensen, {B H}",

year = "1992",

month = oct,

language = "English",

volume = "71",

pages = "305--7",

journal = "Pharmacology and Toxicology",

issn = "0901-9928",

publisher = "Munksgaard ",

number = "4",

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TY - JOUR

T1 - Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations

AU - Christrup, Lona Louring

AU - Bonde, J

AU - Rasmussen, S N

AU - Sonnergaard, J M

AU - Jensen, B H

PY - 1992/10

Y1 - 1992/10

N2 - Single-dose and steady state pharmacokinetics of diltiazem administered in two different oral formulations were assessed with particular reference to rate and extent of absorption. Following single dose administration a significant difference in tmax was observed (2.9 +/- 1.9 and 6.8 +/- 2.6 hr respectively) whereas differences in AUC, t1/2 and Cmax were not significant. The AUC (mean +/- S.D.) values following single dose administration of Cardil and Cardizem were 678.4 +/- 321.5 and 948.6 +/- 580.6 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.89 and 0.44-1.34 respectively. At steady-state a significant difference between Cmax/Cmin and tmax was seen Cmax/Cmin being 4.9 and 3.2 respectively and Tmax being 2.7 +/- 2.0 and 6.0 +/- 2.8 hr respectively, whereas Cmax and AUC did not differ significantly. The AUC (mean +/- S.D.) values in steady state of Cardil and Cardizem were 880.1 +/- 399.8 and 1056.8 +/- 509.8 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.96 and 0.66-1.26 respectively. Although the observed ratios AUCCardil/AUCCardizem in both the single-dose and the steady-state study do not differ significantly from 1.0, the confidence limits exceed the acceptable values given by Poulsen & Juul (personal communication 1990) (a 20% decrease or increase of the ratio to 0.8 or 1.2).

AB - Single-dose and steady state pharmacokinetics of diltiazem administered in two different oral formulations were assessed with particular reference to rate and extent of absorption. Following single dose administration a significant difference in tmax was observed (2.9 +/- 1.9 and 6.8 +/- 2.6 hr respectively) whereas differences in AUC, t1/2 and Cmax were not significant. The AUC (mean +/- S.D.) values following single dose administration of Cardil and Cardizem were 678.4 +/- 321.5 and 948.6 +/- 580.6 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.89 and 0.44-1.34 respectively. At steady-state a significant difference between Cmax/Cmin and tmax was seen Cmax/Cmin being 4.9 and 3.2 respectively and Tmax being 2.7 +/- 2.0 and 6.0 +/- 2.8 hr respectively, whereas Cmax and AUC did not differ significantly. The AUC (mean +/- S.D.) values in steady state of Cardil and Cardizem were 880.1 +/- 399.8 and 1056.8 +/- 509.8 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.96 and 0.66-1.26 respectively. Although the observed ratios AUCCardil/AUCCardizem in both the single-dose and the steady-state study do not differ significantly from 1.0, the confidence limits exceed the acceptable values given by Poulsen & Juul (personal communication 1990) (a 20% decrease or increase of the ratio to 0.8 or 1.2).

KW - Absorption

KW - Administration, Oral

KW - Adult

KW - Biological Availability

KW - Chromatography, High Pressure Liquid

KW - Delayed-Action Preparations

KW - Diltiazem

KW - Female

KW - Humans

KW - Male

KW - Tablets

M3 - Journal article

C2 - 1454755

SN - 0901-9928

VL - 71

SP - 305

EP - 307

JO - Pharmacology and Toxicology

JF - Pharmacology and Toxicology

IS - 4

ER -

Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations

Abstract

Keywords

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