Preterm BirthPhase 1NCT03668860
India Dexamethasone and Betamethasone
A Phase 1 study testing Dexamethasone 4 mg/ml, Betamethasone 4 mg/ml and Celestone Soluspan 6Mg/Ml Suspension for Injection in people with Preterm Birth and Antenatal Corticosteroids, run by Children's Hospital Medical Center, Cincinnati at 1 site in India.
Trial summary
An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Antenatal Corticosteroids
- What is being tested?
- Dexamethasone 4 mg/ml, Betamethasone 4 mg/ml and Celestone Soluspan 6Mg/Ml Suspension for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 20 Sep 2018to 31 Dec 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Healthy, adult, female subjects within the age range of 18 to 40 years [both inclusive].
- - Weight not less than 45 kg.
- - BMI [18.00 to 25.00 kg/m2] [both inclusive].
- - Willingness to provide written informed consent to participate in the study.
- - Without any medical or surgical condition that might interfere with gastrointestinal absorption of the study drug.
- - Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
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- - Subjects should be non-smoker or moderate smokers (less than 10 cigarettes a day), and should not be consuming tobacco containing products [ defined as someone who has stopped smoking for a year from the date of screening].
- - Subject must be either a non-drinker or an occasional drinker of alcohol and agreed to abstain from alcoholic consumption during the study duration.
- - Absence of disease markers of HIV I and 2, Hepatitis Band C and Syphilis.
- - Female subjects of childbearing potential must be using two acceptable methods of contraception, ( e.g., intra-uterine device (IUD) plus condom, spermicidal gel plus condom, diaphragm plus condom, progestin only implants and long acting injectables (Depo Provera), etc.). These measures are required during the study and for at least two weeks after the last dose and conveyed during the inform consent process (or) postmenopausal women for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy have been performed).
- - Subject should be literate.
Who cannot join
- - History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro- intestinal, endocrine, immunologic, dermatologic, neurological, HEENT (Head, Eyes, Ears, Nose And Throat), psychiatric disease/ disorder.
- - History or presence of significant:
- Asthma, urticaria or other allergic type reactions or hypersensitivity after taking Dexamethasone or Betamethasone or any other drug.
- Ulceration or history of gastric and / or duodenal ulcer.
- Stomach or intestinal bleeding.
- Jaundice in the past 6 months.
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- - History of drug abuse.
- - History of renal impairment or severe hepatic impairment.
- - History or presence of psychiatric disorders
- - Have donated 500 mL or more blood within 90 days before receiving the first dose of study drug.
- - Major illness during 3 months before screening.
- - Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.
- - Any difficulty in accessibility of forearm veins for cannulation or blood sampling and or difficulty with donating blood.
- - Refuse to abstain from food for at least 10 h prior to dosing and for at least 4 h after dosing in each period and for at least 10 h before and at least 4 h after collecting the baseline assessment blood sample in Period 1.
- - Refuse to abstain from fluid for at least 1 h before and 1 h after dosing.
- - Refuse to abstain from alcohol for the duration of the study.
- - Positive during breath alcohol test.
- - Positive during urine drug screening.
- - History of difficulty in swallowing study formulations.
- - Received any medication [including over-the-counter products, vitamins, herbal products] for 14 days preceding the study.
- - Use of enzyme modifying drugs, MAO inhibitors within 30 days prior to receiving the first dose of study medication.
- - History of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in of each period.
- - Consumption of xanthine containing food and beverages (chocolates, tea, coffee or cola drinks) for at least 48 hours prior to study check-in.
- - Consumption of grapefruit juice within the 7-days prior to study check-in.
- - Pregnant females as determined by positive test for pregnancy.
- - Lactating females.
- - Investigator/physician feels that it is not in the subject's and/or study's best interest to enroll the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized Study to Compare the Pharmacokinetics and Pharmacodynamics of Single Dose Dexamethasone and Betamethasone Administered Orally and Intramuscularly in Healthy Female Subjects
An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India.
- Conditions
- Preterm Birth, Antenatal Corticosteroids
- Being tested
- Dexamethasone 4 mg/ml, Betamethasone 4 mg/ml, Celestone Soluspan 6Mg/Ml Suspension for Injection, Dexamethasone Oral Tablet, Betamethasone Oral Tablet
- Keywords
- Antenatal Corticosteroids, Betamethasone, Dexamethasone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 mg/mlDrug
Intramuscular. Total dose: 1.5 mL (6 mg)
Betamethasone 4 mg/mlDrug
Intramuscular. Total dose: 1.5 mL (6 mg)
Celestone Soluspan 6Mg/Ml Suspension for InjectionDrug
Intramuscular. Total dose: 1 mL (6 mg)
Dexamethasone Oral TabletDrug
Oral. Total dose: 12 Tablets (6 mg)
Betamethasone Oral TabletDrug
Oral. Total dose: 12 Tablets (6 mg)
| Study group | Role | What they receive |
|---|---|---|
| Treatments A & B (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product A will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product B will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
(Treatment A: Dexamethasone sodium phosphate intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg))
(Treatment B: Betamethasone phosphate solution intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) Receives: Drug: Dexamethasone 4 mg/ml; Drug: Betamethasone 4 mg/ml |
| Treatments B & A (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product B will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product A will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
(Treatment B: Betamethasone phosphate solution intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg))
(Treatment A: Dexamethasone sodium phosphate intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) Receives: Drug: Dexamethasone 4 mg/ml; Drug: Betamethasone 4 mg/ml |
| Treatments C & D (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
(Treatment C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose: 1mL (6mg))
(Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) Receives: Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection; Drug: Dexamethasone Oral Tablet |
| Treatments D & C (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
(Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg))
(Treatment C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg)) Receives: Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection; Drug: Dexamethasone Oral Tablet |
| Treatments E & D (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
(Treatment E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg))
(Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) Receives: Drug: Dexamethasone Oral Tablet; Drug: Betamethasone Oral Tablet |
| Treatments D & E (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
(Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg))
(Treatment E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) Receives: Drug: Dexamethasone Oral Tablet; Drug: Betamethasone Oral Tablet |
| Treatments C & E (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg)
E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg) Receives: Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection; Drug: Betamethasone Oral Tablet |
| Treatments E & C (6 subjects) | Active comparator | After overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm.
Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm.
E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)
C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg) Receives: Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection; Drug: Betamethasone Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of pharmacokinetic parameters of each drug
Plasma concentration versus time curves of Dexamethasone and Betamethasone given orally and intramuscularly to non-pregnant females.
Measured: 23 days
Measurements of pharmacodynamic parameters of each drug
Measurements of glucose, cortisol and lymphocyte population changes versus time resulting from the steroid treatment given orally and intramuscularly to non-pregnant females.
Measured: 23 days
Secondary outcomes (1)
Adverse Events
To monitor the adverse events and to ensure the safety of the subjects. Safety assessments will be analyzed descriptively. All continuous variables will be summarized using the following descriptive statistics: n, mean, standard deviation, median, minimum value, and maximum value. Categorical variables will be summarized using frequency counts and percentages. No formal statistical inferences are planned.
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start20 Sep 2018
- Primary completion28 Feb 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Syngene
- Responsible party
- Sponsor
- Investigators
- Alan Jobe, MD, Ph.D, Study director, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668860
- Sponsor's protocol ID
- CIN001 - India Steroids
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized Study to Compare the Pharmacokinetics and Pharmacodynamics of Single Dose Dexamethasone and Betamethasone Administered Orally and Intramuscularly in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT03668860
- Acronym / sponsor ID
- CIN001 - India Steroids
- Conditions
- Preterm Birth, Antenatal Corticosteroids
- Keywords
- Antenatal Corticosteroids, Betamethasone, Dexamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Syngene
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Sep 2018 (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.
An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Treatments A & B (6 subjects) | Active comparator | Drug: Dexamethasone 4 mg/ml, Drug: Betamethasone 4 mg/mlAfter overnight fasting of at least 10 hours, a single dose of investigational product A will be administered intramuscularly at gluteal or thigh region to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product B will be administered intramuscularly at gluteal or thigh region to each subject in this arm. (Treatment A: Dexamethasone sodium phosphate intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) (Treatment B: Betamethasone phosphate solution intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) |
| Treatments B & A (6 subjects) | Active comparator | Drug: Dexamethasone 4 mg/ml, Drug: Betamethasone 4 mg/mlAfter overnight fasting of at least 10 hours, a single dose of investigational product B will be administered intramuscularly at gluteal or thigh region to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product A will be administered intramuscularly at gluteal or thigh region to each subject in this arm. (Treatment B: Betamethasone phosphate solution intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) (Treatment A: Dexamethasone sodium phosphate intramuscular injection, 4mg/mL - Total dose: 1.5mL (6mg)) |
| Treatments C & D (6 subjects) | Active comparator | Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection, Drug: Dexamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. (Treatment C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose: 1mL (6mg)) (Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) |
| Treatments D & C (6 subjects) | Active comparator | Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection, Drug: Dexamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm. (Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) (Treatment C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg)) |
| Treatments E & D (6 subjects) | Active comparator | Drug: Dexamethasone Oral Tablet, Drug: Betamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. (Treatment E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) (Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) |
| Treatments D & E (6 subjects) | Active comparator | Drug: Dexamethasone Oral Tablet, Drug: Betamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product D will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. (Treatment D: Dexamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) (Treatment E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg)) |
| Treatments C & E (6 subjects) | Active comparator | Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection, Drug: Betamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg) E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg) |
| Treatments E & C (6 subjects) | Active comparator | Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection, Drug: Betamethasone Oral TabletAfter overnight fasting of at least 10 hours, a single dose of investigational product E will be administered orally with 240± 2mL of water in sitting posture at room temperature to each subject in this arm. Following washout period of between 9-12 days and after overnight fasting of at least 10 hours, a single dose of investigational product C will be administered intramuscularly at gluteal or thigh region to each subject in this arm. E: Betamethasone phosphate 0.5mg oral tablets - Total dose: 12 tablets (6mg) C: Celestone Soluspan intramuscular injection, 6mg/mL (3mg phosphate and 3 mg acetate salts) - Total dose 1mL (6mg) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- - Healthy, adult, female subjects within the age range of 18 to 40 years [both inclusive].
- - Weight not less than 45 kg.
- - BMI [18.00 to 25.00 kg/m2] [both inclusive].
- - Willingness to provide written informed consent to participate in the study.
- - Without any medical or surgical condition that might interfere with gastrointestinal absorption of the study drug.
Key exclusion criteria (27 listed)
- - History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro- intestinal, endocrine, immunologic, dermatologic, neurological, HEENT (Head, Eyes, Ears, Nose And Throat), psychiatric disease/ disorder.
- - History or presence of significant:
- - History of drug abuse.
- - History of renal impairment or severe hepatic impairment.
- - History or presence of psychiatric disorders
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 |
|---|---|---|
| Dexamethasone 4 mg/mlIntramuscular. Total dose: 1.5 mL (6 mg) | Drug | Treatments A & B (6 subjects), Treatments B & A (6 subjects) |
| Betamethasone 4 mg/mlIntramuscular. Total dose: 1.5 mL (6 mg) | Drug | Treatments A & B (6 subjects), Treatments B & A (6 subjects) |
| Celestone Soluspan 6Mg/Ml Suspension for InjectionIntramuscular. Total dose: 1 mL (6 mg) | Drug | Treatments C & D (6 subjects), Treatments C & E (6 subjects), Treatments D & C (6 subjects), Treatments E & C (6 subjects) |
| Dexamethasone Oral TabletOral. Total dose: 12 Tablets (6 mg) | Drug | Treatments C & D (6 subjects), Treatments D & C (6 subjects), Treatments D & E (6 subjects), Treatments E & D (6 subjects) |
| Betamethasone Oral TabletOral. Total dose: 12 Tablets (6 mg) | Drug | Treatments C & E (6 subjects), Treatments D & E (6 subjects), Treatments E & C (6 subjects), Treatments E & D (6 subjects) |
Primary outcome
Measurements of pharmacokinetic parameters of each drug
Time frame: 23 days
Plasma concentration versus time curves of Dexamethasone and Betamethasone given orally and intramuscularly to non-pregnant females.
Measurements of pharmacodynamic parameters of each drug
Time frame: 23 days
Measurements of glucose, cortisol and lymphocyte population changes versus time resulting from the steroid treatment given orally and intramuscularly to non-pregnant females.
1 secondary outcome
Adverse Events
Time frame: 23 days
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 Jul 2020.
- 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.
Alan Jobe, MD, Ph.D study director
Children's Hospital Medical Center, Cincinnati
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 Dexamethasone 4 mg/ml, Betamethasone 4 mg/ml and Celestone Soluspan 6Mg/Ml Suspension for Injection in people with Preterm Birth and Antenatal Corticosteroids, run by Children's Hospital Medical Center, Cincinnati at 1 site in India.
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 11 inclusion and 27 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 Jul 2020. 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 India. 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?
Measurements of pharmacokinetic parameters of each drug (time frame: 23 days). The study lists 2 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 Jul 2020.