NCT01566565

The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension

The Safety Evaluation of Theophylline and Bambuterol When Administered Orally Alone and in Combination to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Norwegian Armed Forces Medical Service · Other Government
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, three period, two sequence, single-center, open-label, randomized, crossover study design. Periods I and II consist of the oral administration of either a single dose of theophylline or bambuterol alone, followed by a 7 day wash out interval. Subsequently, Period III consists of the simultaneous administration of both drugs. All subjects are to be confined to the Oslo University Hospital Research Unit throughout all treatment periods \[Study Day 1, 7 and 14\]. A sufficient number of healthy adult subjects will be consented in order to enroll 20 and complete 16 subjects who complete all three periods. Replacement of subjects is permitted, if necessary. Qualified subjects will be randomized into one of two sequences consisting of three Periods as indicated below: -------------Period 1-----Period 2-----Period 3 Sequence A: Treatment 1 Treatment 2 Treatment 3 Sequence B: Treatment 2 Treatment 1 Treatment 3 TREATMENTS: Treatment 1: Theophylline 300 mg. Treatment 2: Bambuterol 20 mg. Treatment 3: Theophylline 300 mg plus Bambuterol 20 mg. After completion of each treatment period, the subjects will proceed to the next period provided no Stopping Rules criteria have been met

Conditions

• High Altitude Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Theophylline and Bambuterol	Treatment 3: Theophylline, 300 mg plus Bambuterol, 20 mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-03-29
• Last updated: 2013-02-26

Locations

1 site across 1 country: Norway