Adrenal InsufficiencyPhase 1NCT03311932
A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects
A Phase 1 study testing Infacort® and Cortef® in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
Trial summary
This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Infacort® and Cortef®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2018to 13 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between 18 and 55 years of age, inclusive (at screening).
- A body mass index (BMI) of 18 to 30 kg/m2 (inclusive)
- No clinically significant abnormal serum biochemistry, haematology or urine examination values, as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test could be repeated at the discretion of the Investigator.
- Negative human immunodeficiency virus (HIV) and hepatitis B and C test results.
- No clinically significant abnormalities in the 12-lead ECG, as defined by the Investigator.
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- No clinically significant deviation outside of the normal ranges for blood pressure and heart rate measurements, as defined by the Investigator.
- Male participants (unless anatomically sterile or abstinence from sexual intercourse was in line with preferred and usual lifestyle) and sexual partners were to use an effective contraception method during the study and for 3 months after the last intervention, for example:
- Established use of oral, injected or implanted hormonal contraceptive.
- Intrauterine device or intrauterine system.
- Condom and diaphragm with spermicide.
- Female participants of childbearing potential (unless abstinence from sexual intercourse was in line with preferred and usual lifestyle) with a negative pregnancy test at screening and on admission, and willing to use an effective method of contraception from the first dose until 3 months after the last intervention, for example:
- Established use of oral / injected / implanted hormonal methods of contraception.
- Intrauterine device or intrauterine system.
- Barrier methods: condom + occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Female participants of non-childbearing potential with negative pregnancy test at screening. For the purposes of the study, non-childbearing was defined as being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). Menopausal status was confirmed at screening by demonstrating that levels of follicle stimulating hormone (FSH) fell within the respective reference range. In the event a participant's menopausal status had been clearly established (for example, the participant indicated she had been amenorrhoeic for 10 years) but FSH levels were not consistent with a post-menopausal condition, determination of eligibility was at the Investigator's discretion following consultation with the Sponsor.
- Participants were available to complete both study periods and the follow-up visit.
- Participants satisfied a medical examiner that they were fit to participate in the study.
- Participants were able to read and understand the ICF and provide written informed consent to take part in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of any medication other than acetaminophen within the 14 days prior to dosing (including topical steroids, vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of infections (systemic fungal and viral infections, acute bacterial infections).
- Current or previous history of tuberculosis.
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- A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone.
- Meeting any of the contraindications for Cortef® and/or dexamethasone, as detailed in the USPI and Summary of Product Characteristics (SmPC).
- A clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity or marketed drug clinical study within the previous 3 months or, five half-lives of study drug, whichever is the longer period. (NB. the three-month washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Participants who had consumed more than 2 units of alcohol per day within the 7 days prior to the first dose or had consumed any alcohol within the 48-hour period prior to the first dose.
- Donation or receipt of equal to or greater than 450 mL of blood within the previous three months.
- Participants who smoked (or ex-smokers who had smoked within the 6 months prior to the first dose). This included e-cigarette and shisha users.
- Participants who worked shifts (i.e. regularly alternated between days, afternoons and nights).
- Vegetarians, vegans or those with other dietary restrictions which meant they were unable to consume the standardised high-fat breakfast (applicable to Part 2 only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Single Centre, Open-label, Randomised, Single Dose, Two-period, Crossover, Relative Bioavailability Study of Infacort® Versus Cortef® in Dexamethasone-suppressed Healthy Adult Male and Female Subjects in the Fasted and Fed States.
This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.
Read the detailed description
The study was conducted in two parts (Part 1 and 2) which were not performed sequentially. In Part 1, 26 subjects were dosed in a fasted condition and in Part 2, 25 subjects were dosed in a fed condition. Each part comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.
Screening assessments (for Parts 1 and 2) were conducted within the 28 days before the first administration of a study intervention. Eligible participants were asked to return for the 2 treatment periods. Continued eligibility was confirmed pre-dose for each treatment period.
Part 1 (fasted state): Treatment Periods: Eligible participants received a single dose of each study intervention over 2 treatment periods (1 per treatment period). Each treatment period was approximately 1.5 days in duration. Participants arrived at the Clinical Unit on Day -1 and dexamethasone 1 mg was administrated at approximately 22:00 hours and then again at approximately 06:00 and 12:00 of Day 0 of each treatment period to suppress endogenous cortisol production. The study intervention was administered at approximately 08:00 on Day 0 in the fasted state (after an overnight fast of at least 10 hours). Participants were discharged following the 12-hour post-dose blood sampling and consumption of a snack (Day 0).
Part 2 (fed state): The same procedures were followed as for Part 1 except that study interventions were administered in a fed condition (30 minutes after the start of a standardised high-fat breakfast). PK samples in both study parts were collected pre-dose and up to 12 hours post-dose (19 samples for each treatment period) for measurement of cortisol levels. Safety was evaluated throughout the study. There was at least a 7-day washout period (up to a maximum of 14 days) between dose administrations. After completion of both study periods, participants were to return 7±2 days later for a final follow-up visit.
- Conditions
- Adrenal Insufficiency
- Being tested
- Infacort®, Cortef®
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infacort®Drug
Immediate release multiparticulate formulation (granules) of hydrocortisone
Cortef®Drug
Immediate release hydrocortisone tablets
| Study group | Role | What they receive |
|---|---|---|
| Cortef® Tablets - fasted | Active comparator | Single dose of 20mg Cortef® Tablets - fasted arm Receives: Drug: Cortef® |
| Infacort® - fasted | Experimental | Single dose of 20mg Infacort® - fasted arm Receives: Drug: Infacort® |
| Cortef® Tablets - fed | Active comparator | Single dose of 20mg Cortef® Tablets - fed arm Receives: Drug: Cortef® |
| Infacort® - fed | Experimental | Single dose of 20mg Infacort® - fed arm Receives: Drug: Infacort® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters for serum cortisol - Maximum serum concentration (Cmax)
Comparing the maximum serum cortisol concentration (Cmax) of Infacort® compared to Cortef® immediate release hydrocortisone tablets.This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Area under the serum cortisol concentration-time curve (AUC0-t)
Comparing the total drug exposure over time for Infacort® compared to Cortef®. This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5 , 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Area under the curve extrapolated to infinity (AUC0-inf)
Comparing the total drug exposure over time for Infacort® compared to Cortef® extrapolated to infinity from dosing time, based on the last observed concentration. This This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5 , 6, 8, 10 and 12 hours; in both periods
Secondary outcomes (9)
Adverse events (AEs)
AEs observed throughout the study
Measured: Through study completion - approximately 6 weeks
Vital signs
Observed changes in vital signs data during the course of the study
Measured: Through study completion - approximately 6 weeks
Electrocardiogram (ECG)
Observed changes in ECG data during the course of the study
Measured: Through study completion - approximately 6 weeks
Safety Laboratory Data
Observed changes in Safety Laboratory data during the course of the study
Measured: Through study completion - approximately 6 weeks
Pharmacokinetic parameters for serum cortisol - Time to maximum cortisol concentration (Tmax)
This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Elimination rate constant (Kel)
This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Terminal half life (t 1/2)
This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Serum cortisol clearance (CL/F)
Calculated as Dose / AUC0-inf. This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Distribution during terminal elimination (Vz/F)
Volume of distribution based on the terminal elimination phase following extravascular administration derived from baseline adjusted and unadjusted serum cortisol.
Measured: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start16 Apr 2018
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Brush Clinical Research Ltd., Voet Consulting, Bionical-Emas Pharma Ltd, Medical Matters International Ltd, Nichol Pharma Services Ltd.
- Responsible party
- Sponsor
- Investigators
- A Koch, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311932
- Sponsor's protocol ID
- Infacort 007
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Single Centre, Open-label, Randomised, Single Dose, Two-period, Crossover, Relative Bioavailability Study of Infacort® Versus Cortef® in Dexamethasone-suppressed Healthy Adult Male and Female Subjects in the Fasted and Fed States.
- ClinicalTrials.gov ID
- NCT03311932
- Acronym / sponsor ID
- Infacort 007
- Conditions
- Adrenal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Brush Clinical Research Ltd., Voet Consulting, Bionical-Emas Pharma Ltd, Medical Matters International Ltd, Nichol Pharma Services Ltd.
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.
Detailed description
The study was conducted in two parts (Part 1 and 2) which were not performed sequentially. In Part 1, 26 subjects were dosed in a fasted condition and in Part 2, 25 subjects were dosed in a fed condition. Each part comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.
Screening assessments (for Parts 1 and 2) were conducted within the 28 days before the first administration of a study intervention. Eligible participants were asked to return for the 2 treatment periods. Continued eligibility was confirmed pre-dose for each treatment period.
Part 1 (fasted state): Treatment Periods: Eligible participants received a single dose of each study intervention over 2 treatment periods (1 per treatment period). Each treatment period was approximately 1.5 days in duration. Participants arrived at the Clinical Unit on Day -1 and dexamethasone 1 mg was administrated at approximately 22:00 hours and then again at approximately 06:00 and 12:00 of Day 0 of each treatment period to suppress endogenous cortisol production. The study intervention was administered at approximately 08:00 on Day 0 in the fasted state (after an overnight fast of at least 10 hours). Participants were discharged following the 12-hour post-dose blood sampling and consumption of a snack (Day 0).
Part 2 (fed state): The same procedures were followed as for Part 1 except that study interventions were administered in a fed condition (30 minutes after the start of a standardised high-fat breakfast). PK samples in both study parts were collected pre-dose and up to 12 hours post-dose (19 samples for each treatment period) for measurement of cortisol levels. Safety was evaluated throughout the study. There was at least a 7-day washout period (up to a maximum of 14 days) between dose administrations. After completion of both study periods, participants were to return 7±2 days later for a final follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cortef® Tablets - fasted | Active comparator | Drug: Cortef®Single dose of 20mg Cortef® Tablets - fasted arm |
| Infacort® - fasted | Experimental | Drug: Infacort®Single dose of 20mg Infacort® - fasted arm |
| Cortef® Tablets - fed | Active comparator | Drug: Cortef®Single dose of 20mg Cortef® Tablets - fed arm |
| Infacort® - fed | Experimental | Drug: Infacort®Single dose of 20mg Infacort® - fed arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Healthy males and females between 18 and 55 years of age, inclusive (at screening).
- A body mass index (BMI) of 18 to 30 kg/m2 (inclusive)
- No clinically significant abnormal serum biochemistry, haematology or urine examination values, as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test could be repeated at the discretion of the Investigator.
- Negative human immunodeficiency virus (HIV) and hepatitis B and C test results.
Key exclusion criteria (16 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of any medication other than acetaminophen within the 14 days prior to dosing (including topical steroids, vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of infections (systemic fungal and viral infections, acute bacterial infections).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infacort®Immediate release multiparticulate formulation (granules) of hydrocortisone | Drug | Infacort® - fasted, Infacort® - fed |
| Cortef®Immediate release hydrocortisone tablets | Drug | Cortef® Tablets - fasted, Cortef® Tablets - fed |
Primary outcome
Pharmacokinetic parameters for serum cortisol - Maximum serum concentration (Cmax)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Comparing the maximum serum cortisol concentration (Cmax) of Infacort® compared to Cortef® immediate release hydrocortisone tablets.This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Pharmacokinetic parameters for serum cortisol - Area under the serum cortisol concentration-time curve (AUC0-t)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5 , 6, 8, 10 and 12 hours; in both periods
Comparing the total drug exposure over time for Infacort® compared to Cortef®. This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Pharmacokinetic parameters for serum cortisol - Area under the curve extrapolated to infinity (AUC0-inf)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5 , 6, 8, 10 and 12 hours; in both periods
Comparing the total drug exposure over time for Infacort® compared to Cortef® extrapolated to infinity from dosing time, based on the last observed concentration. This This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
9 secondary outcomes
Adverse events (AEs)
Time frame: Through study completion - approximately 6 weeks
Vital signs
Time frame: Through study completion - approximately 6 weeks
Electrocardiogram (ECG)
Time frame: Through study completion - approximately 6 weeks
Safety Laboratory Data
Time frame: Through study completion - approximately 6 weeks
Pharmacokinetic parameters for serum cortisol - Time to maximum cortisol concentration (Tmax)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Elimination rate constant (Kel)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Terminal half life (t 1/2)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Serum cortisol clearance (CL/F)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Pharmacokinetic parameters for serum cortisol - Distribution during terminal elimination (Vz/F)
Time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Koch principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infacort® and Cortef® in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters for serum cortisol - Maximum serum concentration (Cmax) (time frame: Blood samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours; in both periods). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.