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India Dexamethasone and Betamethasone

NCT03668860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-07-14

No results posted yet for this 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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Syngene

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2019-02-28
Completion
2019-12-31
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668860 on ClinicalTrials.gov