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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Syngene | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)) |
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| 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)) |
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| 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)) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4 mg/ml | Drug | Intramuscular. Total dose: 1.5 mL (6 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of pharmacokinetic parameters of each drug | Plasma concentration versus time curves of Dexamethasone and Betamethasone given orally and intramuscularly to non-pregnant females. | 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. | 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion 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:
- 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.
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| Name | Affiliation | Role |
|---|---|---|
| Alan Jobe, MD, Ph.D | Children's Hospital Medical Center, Cincinnati | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syngene International Limited, Tower I | Bangalore | 560 100 | India |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D001623 | Betamethasone |
| C018230 | betamethasone acetate phosphate |
| D013535 | Suspensions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| 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)) |
|
| 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)) |
|
| 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)) |
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| 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) |
|
| 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) |
|
| Betamethasone 4 mg/ml | Drug | Intramuscular. Total dose: 1.5 mL (6 mg) |
|
| Celestone Soluspan 6Mg/Ml Suspension for Injection | Drug | Intramuscular. Total dose: 1 mL (6 mg) |
|
| Dexamethasone Oral Tablet | Drug | Oral. Total dose: 12 Tablets (6 mg) |
|
| Betamethasone Oral Tablet | Drug | Oral. Total dose: 12 Tablets (6 mg) |
|
| 23 days |
| D000091642 | Urogenital Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |