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February 1, 1985Clinical Pharmacology & Therapeutics

Absolute bioavailability of amiodarone in normal subjects

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Key result

Oral amiodarone demonstrated a mean absolute bioavailability of 65% ± 22% compared to intravenous injection, with bioequivalence across different oral formulations.

Why the study?

What is the absolute and relative bioavailability of different oral forms of amiodarone compared to intravenous administration in normal subjects?

Population

12 normal subjects

Comparison

Amiodarone 400 mg oral vs Amiodarone 5 mg/kg intravenous (IV)

Design

Other

Authors

SPSuzanne PourbaixCentre hospitalier régional de la CitadelleYBYves BergerJohns Hopkins UniversityJDJean‐Pierre DesagerUCLouvain

Discussion

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Implication

May permit substitution among oral amiodarone products; leaves open efficacy equivalence in clinical practice.

Structured PICO

What is the absolute and relative bioavailability of different oral forms of amiodarone compared to intravenous administration in normal subjects?

P
Population
12 normal subjects evaluated for the relative and absolute bioavailability of different oral forms of amiodarone.
I
Intervention
Amiodarone 400 mg oral (administered as two 200-mg commercial tablets, two 200-mg new formulation tablets, or 400 mg in a drinkable solution)
C
Comparator
Amiodarone 5 mg/kg intravenous (IV)
O
Outcome
Relative and absolute bioavailability (calculated by comparison of AUCs after oral dosing with those after intravenous injection)surrogate

Oral amiodarone has a mean absolute bioavailability of 65%, with incomplete absorption likely due to a first-pass effect rather than formulation dissolution characteristics.

Cite This Study

Pourbaix et al. (1985) studied Healthy subjects (n=12). Oral amiodarone vs. Intravenous amiodarone (5 mg/kg) was evaluated on Absolute bioavailability. Oral amiodarone demonstrated a mean absolute bioavailability of 65% ± 22% compared to intravenous injection, with bioequivalence across different oral formulations.

synapsesocial.com/papers/6a6cebe5660549caf2c2b0dehttps://doi.org/10.1038/clpt.1985.22
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Also Consider

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  1. 1Pharmacokinetics of Amiodarone in Man1982 · 93 citations
  2. 2Comparative Bioavailability of a Premixed, Ready‐to‐Use Formulation of Intravenous Amiodarone With Traditional Admixture in Healthy Subjects2011 · 11 citations
  3. 3Evaluation of the pharmacokinetics and bioavailability of intravenously and orally administered amiodarone in horses2006 · 22 citations
  4. 4Bioequivalence of 2 Intravenous Amiodarone Formulations in Healthy Participants2009 · 14 citations
  5. 5Amiodarone kinetics after oral doses1982 · 128 citations