Trial reportBritish journal of clinical pharmacology2000
The effects of ketoconazole on ziprasidone pharmacokinetics--a placebo-controlled crossover study in healthy volunteers.
Trial report in British journal of clinical pharmacology, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed, 73 citations in OpenAlex.
- The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers.British journal of clinical pharmacology · 2000Trial
- Metabolic and Endocrine ADRs of Atypical Antipsychotics (AAPs) in Paediatric Patients with Autism Spectrum Disorder (ASD): A Review of Prevalence, Risk Factors, and Implications for Clinical Monitoring.Journal of clinical medicine · 2025Review
- Clinically Relevant Interactions between Atypical Antipsychotics and Anti-Infective Agents.Pharmaceuticals (Basel, Switzerland) · 2020Review
- Physiologically-based pharmacokinetics of ziprasidone in pregnant women.British journal of clinical pharmacology · 2019Article
- Predicting QT prolongation in humans during early drug development using hERG inhibition and an anaesthetized guinea-pig model.British journal of pharmacology · 2008Article
- Ziprasidone for the treatment of acute manic or mixed episodes associated with bipolar disorder.CNS drugs · 2007Review
- Expert Canadian consensus suggestions on the rational, clinical use of ziprasidone in the treatment of schizophrenia and related psychotic disorders.Neuropsychiatric disease and treatment · 2005Article
- Pharmacokinetics and therapeutics of acute intramuscular ziprasidone.Clinical pharmacokinetics · 2005Review
- Pharmacokinetic factors in the adverse cardiovascular effects of antipsychotic drugs.Clinical pharmacokinetics · 2004Review
- Interactions between the cytochrome P450 system and the second-generation antipsychotics.Journal of psychiatry & neuroscience : JPN · 2003Review
- Factors affecting the clinical development of cytochrome p450 3A substrates.Clinical pharmacokinetics · 2003Review
- Review
- Review
- Review
- Biotransformation of post-clozapine antipsychotics: pharmacological implications.Clinical pharmacokinetics · 2000Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo assess the effects of multiple oral doses of ketoconazole on the single-dose pharmacokinetics of oral ziprasidone HCl.
methodsThis was a 14-day, open-label, randomized, crossover study in 14 healthy subjects aged 18-31 years. Group 1 received oral ketoconazole 400 mg once daily for 6 days, followed by a 2 day wash-out period and 6 days of placebo administration. Group 2 received placebo followed by ketoconazole. Single oral doses of ziprasidone HCl 40 mg were administered on days 5 and 13 in both groups. Ziprasidone pharmacokinetic parameters were compared between placebo and ketoconazole administration periods.
resultsCo-administration of ziprasidone with ketoconazole was associated with a modest increase in ziprasidone exposure; mean ziprasidone AUC(0,infinity) increased by 33%, from 899 ng ml(-1) h with placebo to 1199 ng ml(-1) h with ketoconazole. Mean Cmax increased by 34%, from 89 ng ml(-1) to 119 ng ml(-1), respectively. The treatment effect on both of these parameters was statistically significant (P<0.02). Most adverse events were of mild intensity. There were no serious adverse events, laboratory abnormalities, abnormal ECGs, or clinically significant alterations in vital signs throughout the study.
conclusionsThe concurrent administration of ketoconazole and ziprasidone led to modest, statistically significant increases in ziprasidone exposure, although the changes seen were not considered clinically relevant. This suggests that other inhibitors of CYP3A4 are unlikely to significantly affect the pharmacokinetics of ziprasidone.
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