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Oral bioavailability and tolerability of hydrocortisone tablets vs hydrocortisone sodium phosphate orodispersible films in children and adolescents with adrenal insufficiency

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What is this study about?

The trial focuses on children and adolescents who have primary adrenal insufficiency, a condition where the adrenal glands do not make enough natural hormones. The medicine being tested is hydrocortisone, which replaces the missing hormone. Two ways of taking the medicine are compared: a small, thin orodispersible film that dissolves in the mouth, and a regular oral tablet.

The purpose of the study is to see how much of the medicine is absorbed from the film compared with the tablet. Participants will receive each form of the medicine on separate days, and simple blood and saliva samples will be taken to measure hormone levels, including the hormone called ACTH. They will also be asked about how the film tastes and how easy it is to use, and any side effects will be recorded. The whole study lasts only a short period for each participant.

1 initial visit and consent

you arrive at the study site after agreeing to participate. the study staff confirm that you have primary adrenal insufficiency and complete any required paperwork.

2 baseline measurements

baseline blood, saliva, and urine samples are collected to establish your normal levels of hydrocortisone, cortisone, ACTH, glucose, and electrolytes (sodium and potassium).

your weight and other health information are recorded to help determine the appropriate study dose.

3 first medication period – hydrocortisone tablets

you receive hydrocortisone in tablet form (available as Acecort 5 mg or Acecort 1 mg film‑coated tablets). the exact dose, how often you take it, and how long you take it are specified in the study instructions.

after taking the tablet, a series of blood samples are drawn over several hours to measure the drug’s concentration in your blood (parameters such as AUC, Cmax, and tmax).

saliva samples are also collected at the same time points to compare saliva and blood levels.

urine is collected for an 8‑hour period to assess how much hydrocortisone is excreted.

4 second medication period – hydrocortisone orodispersible film

you receive a 2‑dimensional printed hydrocortisone orodispersible film. the film contains hydrocortisone sodium phosphate and is taken as directed by the study protocol.

the same schedule of blood, saliva, and urine collections is performed to compare the film with the tablet formulation.

5 palatability and ease‑of‑use assessment

you are asked to rate the taste of the orodispersible film and how easy it was to take, using a simple questionnaire.

6 safety monitoring

any adverse events you experience are recorded, including their frequency, severity, and whether they are thought to be related to the study medication.

the study team reviews these reports throughout the trial to ensure your safety.

7 final visit and study completion

you return for a final visit where the collected data are reviewed, and you receive information about the overall study outcome.

your participation in the trial ends after this visit.

Who Can Join the Study?

  • You and your legal guardian must sign a written informed consent form, and you must also give your own agreement (assent) if you are old enough.
  • You must be willing to use a reliable contraception method (condoms for males and a highly effective method for females or their partners) during the study and for one week after the last study medication.
  • You must be ready to follow any pandemic‑related rules that may be put in place while the study is running.
  • You must agree to follow the study’s specific lifestyle and diet instructions.
  • You must be between 7 and 17 years old when you sign the consent form.
  • You must have a doctor‑confirmed diagnosis of primary adrenal insufficiency (including classic or non‑classic congenital adrenal hyperplasia or autoimmune form) and be taking regular steroid replacement therapy.
  • Your dose of hydrocortisone (the steroid you normally take) must have been steady for at least two weeks before the first study visit.
  • If you also take fludrocortisone, that dose must have been steady for at least one month before screening, and a blood test called plasma renin activity must be within a normal range (not too high or too low) while you are on your usual salt intake.
  • A blood test for ACTH (a hormone that tells the adrenal glands what to do) must be less than twice the upper normal limit.
  • Blood levels of 17‑OHP and androstenedione (hormones related to adrenal function) must be in the range that your pediatric endocrinologist considers appropriate.
  • You must understand the study, be able to follow all study procedures, and be willing to do so.
  • If you are able to become pregnant or father a child and are sexually active, you must agree to use a highly effective birth‑control method throughout the study and for one week after the last dose of the study medication (IMP – investigational product).

Who Cannot Join the Study?

  • Anyone who does not want to follow the study rules or cannot follow them, as decided by the doctor.
  • People who have had cancer (a disease where cells grow uncontrollably) unless it was completely cured.
  • People with any type of diabetes (a condition where blood sugar is too high) as defined by the American Diabetes Association.
  • Anyone with an acute (sudden) or chronic (long‑lasting) illness, or any health problem that could change how the body absorbs, moves, breaks down, or removes the study drug.
  • People who have had severe allergic or anaphylactic (a very serious, whole‑body allergic) reactions to the study drug, other medicines, foods, or any major allergies.
  • Anyone who tests positive for illegal drugs in a urine screening test at the screening visit.
  • People who have taken another investigational medicinal product (IMP) in another study within the last 30 days or 5 half‑lives of that drug, or who are currently enrolled in another drug study.
  • Anyone who received a vaccine less than 2 weeks before the first dose of the study drug (or less than 4 weeks if it was a live‑attenuated vaccine, which contains weakened germs).
  • People who test positive for HIV (human immunodeficiency virus), hepatitis C virus, or hepatitis B surface antigen (a marker of hepatitis B infection).
  • Anyone known to be allergic to the oral dissolving film (ODF) or any of its inactive ingredients (excipients).
  • People who currently have a substance or alcohol dependence (for example, drinking more than 12 g of alcohol per day for females or more than 24 g per day for males) or who cannot agree not to drink alcohol for 24 hours before the pharmacokinetic study days.
  • Anyone who works for the study investigators, the sponsor, or the study site, or is a close family member of those employees.
  • People who cannot agree not to smoke during the study days.
  • Anyone who changed other medicines within two weeks before the first visit, especially medicines that affect cytochrome P450 enzymes (proteins that help the body process many drugs).
  • People who lost a large amount of blood (at least 3 % of total blood volume, roughly 75 mL per kilogram of body weight) within 8 weeks before the first day of the study.
  • Participants with any of the following lab results at screening (minor differences may be allowed if the doctor thinks they are not important):
    • Hemoglobin (Hb) less than 11 g/dL (a low level of the protein that carries oxygen in red blood cells).
    • White blood cell count less than 4.0 × 10³ per mm³ (low immune cells).
    • Platelet count less than 100,000 per mm³ (low cells that help blood clot).
    • Absolute neutrophil count less than 1.0 × 10³ per mm³ (low type of white blood cell).
    • Estimated glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m² (reduced kidney function, calculated with the Schwartz formula for ages 12‑17).
    • Total bilirubin more than 1.5 times the upper limit of normal (unless caused by Gilbert’s syndrome, a harmless liver condition).
    • ALT or AST more than 2 times the upper limit of normal (liver enzymes that indicate liver injury).
    • Creatine kinase (CK) outside the normal range (muscle enzyme; participants with CK 1.5‑3 times the upper limit may be allowed if troponin T, a heart injury marker, is negative).
    • Serum sodium less than 132 mmol/L (low blood sodium).
  • Anyone who is living in a care facility because of a court order or government placement.
  • People with any medical condition that might need extra treatment, make it unlikely they can finish the study, or create an unsafe risk from the study drug.
  • Anyone the doctor thinks is at high risk for an adrenal crisis (a dangerous drop in hormone levels), such as those with repeated past crises or recent episodes.
  • Women who are pregnant or breastfeeding.
  • People with late‑onset congenital adrenal hyperplasia (a genetic hormone disorder that appears later in life).
  • Individuals with secondary adrenal insufficiency (low hormone production caused by problems outside the adrenal glands).
  • Anyone currently taking other glucocorticoids (steroid medicines such as prednisolone or dexamethasone) or modified‑release hydrocortisone preparations.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Ufgwodznubooognkqybwt Hmkipwvawr Akc Heidelberg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
01.08.2026

Trial locations

Investigated Drugs:

Acecort is a small, film‑coated tablet that contains the hormone hydrocortisone. It is taken by mouth and is the standard form of medication used to replace the missing cortisol in children and adolescents with primary adrenal insufficiency. In this study the tablet serves as the reference product against which the new film is compared.

2D printed Hydrocortisone orodispersible films are thin, printable strips that contain hydrocortisone sodium phosphate. The film dissolves quickly on the tongue without needing water, making it easier for children to take. The trial is testing how well this film is absorbed into the body and how well it is tolerated, compared with the traditional tablet.

Investigated Diseases:

Primary adrenal insufficiency – Primary adrenal insufficiency is a condition where the adrenal glands cannot produce enough cortisol. It develops when the adrenal cortex is damaged or absent, leading to a gradual decline in hormone output. As cortisol levels fall, the body’s ability to respond to stress and maintain metabolism diminishes. Over time, the deficiency can cause increasing fatigue, low blood pressure, and electrolyte changes. The condition often progresses slowly, with symptoms becoming more noticeable during periods of physical or emotional stress.

Trial ID:
2026-526416-37-00
Protocol code:
PK054
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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