drugset / Trial / NCT03668860
India Dexamethasone and Betamethasone
Phase 1
Completed
48 enrolled
Children's Hospital Medical Center, Cincinnati
Bill and Melinda Gates Foundation · collabSyngene · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2018-09-20
- Primary completion
- 2019-02-28
- Completion
- 2019-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Betamethasone | Other / unclassified | 6 mg | Intramuscular |
| Comparator | Betamethasone | Other / unclassified | 6 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 6 mg | Intramuscular |
| Comparator | Dexamethasone | Small molecule | 6 mg | Oral |
Indications
No indication recorded.