High Altitude Pulmonary Hypertension Clinical Trial
Official title:
The Safety Evaluation of Theophylline and Bambuterol When Administered Orally Alone and in Combination to Healthy Volunteers
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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