Trial reportClinical pharmacology in drug development2019
Pharmacokinetics and Comparative Bioavailability of a Levothyroxine Sodium Oral Solution and Soft Capsule.
Trial report in Clinical pharmacology in drug development, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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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.
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.
Who cites it
14 citing papers in PubMed.
- A Novel Levothyroxine Solution Results in Similar Bioavailability Whether Taken 30 or Just 15 Minutes Before a High-Fat High-Calorie Meal.Thyroid : official journal of the American Thyroid Association · 2022Trial
- Comparative efficacy of early morning versus bedtime administration of levothyroxine in children with hypothyroidism: a prospective, open label, randomized, case-control study.Pediatric endocrinology, diabetes, and metabolism · 2021Trial
- Comparison of tablet versus liquid ethanol-free Levothyroxine in thyroidectomised patients.Endocrine · 2025Article
- Liquid L-T4 therapy in hypothyroid patients with gastric diseases, an observational study.Frontiers in endocrinology · 2024Observational
- Preparation of altrenogest soft capsules and their bioequivalence in gilts.Frontiers in veterinary science · 2024Article
- The Bioavailability of Drugs-The Current State of Knowledge.Molecules (Basel, Switzerland) · 2023Review
- Ionic Levothyroxine Formulations: Synthesis, Bioavailability, and Cytotoxicity Studies.International journal of molecular sciences · 2023Article
- Levothyroxine: Conventional and Novel Drug Delivery Formulations.Endocrine reviews · 2023Review
- Pharmacokinetics and Clinical Implications of Two Non-Tablet Oral Formulations of L-Thyroxine in Patients with Hypothyroidism.Journal of clinical medicine · 2022Review
- Article
- Tea consumption affects the absorption of levothyroxine.Frontiers in endocrinology · 2022Article
- Article
- Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"Clinical pharmacokinetics · 2020Article
- Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution.Advances in therapy · 2019Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A new formulation of levothyroxine sodium has been developed in the form of an oral solution contained in unit-dose ampules. A study has been conducted to compare the bioavailability of levothyroxine sodium oral solution and levothyroxine sodium soft capsule in healthy volunteers under fasting conditions. The rate and extent of absorption of the new levothyroxine solution were also evaluated when administered on dilution in water or directly into the mouth without water. In each period, according to the randomization scheme, subjects were administered single oral doses of either test, as 4 × 150-μg unit-dose ampules, with or without water, or reference, as 4 × 150-μg capsules in a crossover design. Thirty-six subjects were randomized and dosed in this study; of these, 31 completed all study periods. When comparing the solution with the capsule (both products administered with water), the 90% confidence intervals for the ratio of log-transformed values of AUC
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