The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension

Phase 1

Completed

• Conditions: High Altitude Pulmonary Hypertension
• Interventions: Drug: Theophylline and Bambuterol

• Registration Number: NCT01566565
• Lead Sponsor: Norwegian Armed Forces Medical Service

Brief 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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Theophylline	Theophylline and Bambuterol	-
Bambuterol	Theophylline and Bambuterol	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	24 hours after dosing	To assess the Number of Participants with Adverse Events after dosing, as a Measure of Safety and Tolerability
Pharmacokinetic	24 hours after dosing	To assess the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in combination.; PK sample collections for plasma Theophylline and Bambuterol determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post dose

Trial Locations

Locations (1)

Institute of Aviation Medicine, Norwegian Armed Forces Medica; 🇳🇴 Oslo, Norway