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CompletedNCT03668860Updated Jul 14, 2020

India Dexamethasone and Betamethasone

A Phase 1 interventional study of Dexamethasone 4 mg/ml and Betamethasone 4 mg/ml in Preterm Birth and Antenatal Corticosteroids, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in India. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2019, 7 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Preterm Birth
  • Antenatal Corticosteroids

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Keywords

  • Antenatal Corticosteroids
  • Betamethasone
  • Dexamethasone
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 48 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

    • 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].
    • 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.

Exclusion criteria

Exclusion Criteria:

    • 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.
    • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Treatments A & B (6 subjects)

    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))

    Drug: Dexamethasone 4 mg/ml · Drug: Betamethasone 4 mg/ml

  • Active comparator
    Treatments B & A (6 subjects)

    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))

    Drug: Dexamethasone 4 mg/ml · Drug: Betamethasone 4 mg/ml

  • Active comparator
    Treatments C & D (6 subjects)

    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))

    Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection · Drug: Dexamethasone Oral Tablet

  • Active comparator
    Treatments D & C (6 subjects)

    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))

    Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection · Drug: Dexamethasone Oral Tablet

  • Active comparator
    Treatments E & D (6 subjects)

    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))

    Drug: Dexamethasone Oral Tablet · Drug: Betamethasone Oral Tablet

  • Active comparator
    Treatments D & E (6 subjects)

    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))

    Drug: Dexamethasone Oral Tablet · Drug: Betamethasone Oral Tablet

  • Active comparator
    Treatments C & E (6 subjects)

    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)

    Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection · Drug: Betamethasone Oral Tablet

  • Active comparator
    Treatments E & C (6 subjects)

    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)

    Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection · Drug: Betamethasone Oral Tablet

Interventions

  • DrugDexamethasone 4 mg/ml

    Intramuscular. Total dose: 1.5 mL (6 mg)

  • DrugBetamethasone 4 mg/ml

    Intramuscular. Total dose: 1.5 mL (6 mg)

  • DrugCelestone Soluspan 6Mg/Ml Suspension for Injection

    Intramuscular. Total dose: 1 mL (6 mg)

  • DrugDexamethasone Oral Tablet

    Oral. Total dose: 12 Tablets (6 mg)

  • DrugBetamethasone Oral Tablet

    Oral. Total dose: 12 Tablets (6 mg)

06

What researchers measure

Primary outcomes

  1. Measurements of pharmacokinetic parameters of each drug

    Plasma concentration versus time curves of Dexamethasone and Betamethasone given orally and intramuscularly to non-pregnant females.

    Time frame: 23 days

  2. 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.

    Time frame: 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.

    Time frame: 23 days

07

Study locations

1 site
  • Syngene International Limited, Tower I
    Bangalore, 560 100, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03668860
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Bill and Melinda Gates Foundation, Syngene
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Sep 20, 2018
Primary completion
Feb 28, 2019
Completion
Dec 31, 2019
Last update
Jul 14, 2020

Study contacts

Alan Jobe, MD, Ph.D
study director · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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