NCT03668860

India Dexamethasone and Betamethasone

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Birth
• Antenatal Corticosteroids

Interventions

Type	Name	Description
DRUG	Dexamethasone 4 mg/ml	Intramuscular. Total dose: 1.5 mL (6 mg)
DRUG	Betamethasone 4 mg/ml	Intramuscular. Total dose: 1.5 mL (6 mg)
DRUG	Celestone Soluspan 6Mg/Ml Suspension for Injection	Intramuscular. Total dose: 1 mL (6 mg)
DRUG	Dexamethasone Oral Tablet	Oral. Total dose: 12 Tablets (6 mg)
DRUG	Betamethasone Oral Tablet	Oral. Total dose: 12 Tablets (6 mg)

Timeline

• Start date: 2018-09-20
• Primary completion: 2019-02-28
• Completion: 2019-12-31
• First posted: 2018-09-13
• Last updated: 2020-07-14

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study