Evidence map›Paper›PMID 27444039›Full record

Trial reportClinical drug investigation2016

Pharmacokinetic Profile and Palatability of Atomoxetine Oral Solution in Healthy Japanese Male Adults.

Masako Nakano, Jennifer Witcher, Yoichi Satoi, Taro Goto

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Masako NakanoLilly Research Laboratories Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan. nakano_masako@lilly.com.
Jennifer WitcherLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Yoichi SatoiLilly Research Laboratories Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.
Taro GotoLilly Research Laboratories Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThere is a clinical need for a liquid formulation of atomoxetine. We assessed the safety and bioequivalence of an atomoxetine oral solution.

methodsThis was an open-label, randomized, crossover study. Healthy adult male Japanese subjects (n = 42) with a cytochrome P450 2D6 extensive (including intermediate and ultrarapid) metabolizer genotype were administered atomoxetine 50 mg as oral solution and capsules once each, with a washout period >5 days between doses. Blood samples were used to analyze pharmacokinetic parameters, particularly maximum observed drug concentration (C

resultsForty subjects completed the study. Plasma concentration-time profiles of atomoxetine oral solution and capsules were similar, and the statistical analysis of systemic exposure showed that the two formulations were bioequivalent. Adverse events were mild and similar in type and frequency between the formulations. For taste acceptability, only 7.1 % of subjects responded that the oral solution would be difficult to take every day.

conclusionAtomoxetine oral solution is bioequivalent to atomoxetine capsules and potentially fulfills the need for an oral solution atomoxetine formulation that will facilitate treatment of children with attention-deficit hyperactivity disorder.

Indexed as

AdultAtomoxetine HydrochlorideCapsulesChemistry, PharmaceuticalCross-Over StudiesFemaleGenotypeHumansMaleTherapeutic EquivalencyYoung AdultAtomoxetine HydrochlorideCapsules

Identifiers

PMID27444039
PMCPMC5073111

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.