Amlodipine besylate pharmacokinetics vs amlodipine

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Pharmacokinetics of Amlodipine Besylate vs Amlodipine: Salt Formulation Comparisons

Bioequivalence and Absorption: Amlodipine Besylate vs Other Salts

Multiple studies have compared the pharmacokinetics of amlodipine besylate with other amlodipine salt forms, such as maleate, nicotinate, camsylate, and adipate. Across these studies, the key pharmacokinetic parameters—maximum plasma concentration (Cmax), area under the curve (AUC), and time to reach maximum concentration (Tmax)—were found to be very similar between amlodipine besylate and the alternative salt forms. The 90% confidence intervals for the ratios of these parameters consistently fell within the accepted bioequivalence range of 80–125%, indicating that the rate and extent of absorption are equivalent for these formulations 1234+6 MORE.

Pharmacodynamic Effects and Safety Profiles

The pharmacodynamic effects, such as reductions in systolic and diastolic blood pressure and changes in pulse rate, were also similar between amlodipine besylate and other amlodipine salts. No significant differences were observed in blood pressure or pulse rate responses, and all formulations were well tolerated with no serious adverse events reported 1346+2 MORE.

Interchangeability and Clinical Implications

Given the consistent findings of pharmacokinetic and pharmacodynamic equivalence, amlodipine besylate and other amlodipine salt formulations (maleate, nicotinate, camsylate, adipate) can be considered interchangeable in clinical practice. The pharmacokinetic behavior of amlodipine is determined by the amlodipine molecule itself, rather than the specific salt form used in the formulation 38.

Summary

In summary, amlodipine besylate and other amlodipine salt formulations show equivalent pharmacokinetic and pharmacodynamic profiles. This means that switching between these formulations should not affect the drug’s absorption, efficacy, or safety in healthy individuals. All formulations are well tolerated and meet regulatory criteria for bioequivalence 1234+6 MORE.

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Most relevant research papers on this topic

Comparative pharmacokinetic and pharmacodynamic characteristics of amlodipine besylate and amlodipine nicotinate in healthy subjects.

Amlodipine nicotinate and amlodipine besylate show similar pharmacokinetic and pharmacodynamic characteristics, with amlodipine nicotinate showing equivalent absorption rates and pharmacodynamic properties.

RCT

2006·

10citations

·J. Y. Park et al.

International journal of clinical pharmacology and therapeutics·

DOI

Comparative Pharmacokinetics of a Single Oral Dose of Two Formulations of Amlodipine

Amlodipine formulations are bioequivalent, with pharmacokinetic parameters falling within the 80-125% range for pharmacokinetic equivalence.

RCT

2008·

4citations

·J. Pico et al.

Arzneimittel-Forschung (Drug Research)·

DOI

P-250: Amlodipine: pharmacokinetics of the maleate vs besylate salts

Amlodipine maleate (AmVaz) is a bioequivalent therapeutic alternative to amlodipine besylate (Norvasc), with no significant differences in pharmacokinetic parameters between the two formulations.

RCT

2004·

2citations

American Journal of Hypertension·

DOI

Comparisons of the pharmacokinetics and tolerability of fixed-dose combinations of amlodipine besylate/losartan and amlodipine camsylate/losartan in healthy subjects: a randomized, open-label, single-dose, two-period, two-sequence crossover study

An FDC of 6.94 mg amlodipine besylate/5 mg losartan potassium is similar to an FDC of 5 mg amlodipine camsylate/5 mg losartan potassium in pharmacokinetics and tolerability in healthy male subjects.

RCTRigorous Journal

2016·

14citations

·Yoonjung Choi et al.

Drug Design, Development and Therapy·

DOI

Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers.

The newly developed fixed-dose combination of amlodipine adipate/valsartan is bioequivalent and safe to amlodipine besylate/valsartan in healthy volunteers.

RCT

2014·

2citations

·J. Nam et al.

International journal of clinical pharmacology and therapeutics·

DOI

Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects.

The newly developed amlodipine formulation (amlodipine camsylate) and the conventional formulation (amlodipine besylate) are pharmacokinetically equivalent and show similar pharmacodynamic properties in healthy male subjects.

RCT

2004·

52citations

·Ji-Young Park et al.

Clinical therapeutics·

DOI

Assessment of pharmacokinetics and bioequivalence of amlodipine besylate in healthy volunteers

The two formulations of amlodipine besylate are bioequivalent, with pharmacokinetic parameters and bioavailability being 99.23% and 99.24% respectively.

RCT

2006·

0citations

·Zhang Yan

Journal of the Fourth Military Medical University

Single-Dose, Randomized, Crossover Bioequivalence Study of Amlodipine Maleate versus Amlodipine Besylate in Healthy Volunteers

Amlodipine maleate and besylate are bioequivalent and well-tolerated, suggesting they can be used interchangeably in clinical practice.

RCT

2007·

17citations

·F. Mignini et al.

Clinical and Experimental Hypertension·

DOI

Study on the pharmacokinetics and bioequivalence of domestic amlodipine besylate tablets in healthy volunteers

Domestic and imported amlodipine besylate tablets are bioequivalent in terms of pharmacokinetic parameters and relative bioavailability in healthy volunteers.

RCT

2007·

0citations

·Li Fei-er

Chinese Journal of Hospital Pharmacy

Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.

A newly developed dispersible tablet formulation of amlodipine besylate met the regulatory criteria for bioequivalence to an established branded formulation in healthy Chinese adult male volunteers, with both formulations being well-tolerated.

RCT

2009·

38citations

·Yun Liu et al.

Clinical therapeutics·

DOI

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