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The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension

NCT01566565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-02-26

No results posted yet for this study

Summary

This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with the primary objective of testing the safety and tolerability of combined oral doses of theophylline and bambuterol in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in combination. It is hypothesized that the combination of these drugs is generally safe, and that no drug interaction can be observed.

Conditions

  • High Altitude Pulmonary Hypertension

Interventions

DRUG

Theophylline and Bambuterol

Treatment 3: Theophylline, 300 mg plus Bambuterol, 20 mg

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Norwegian Armed Forces Medical Service

    lead OTHER_GOV

Principal Investigators

  • Trond-Eirik Strand, M.D., Ph.D. · Institute of Aviation Medicine, Norwegian Armed Forces Medical

  • Thies Schroeder, Ph.D. · Department of Radiation Oncology, Duke University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Norway

Study Locations

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Entities

Companies

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 NCT01566565 on ClinicalTrials.gov