CompletedPhase 1

Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

Canada66 participantsStarted 2014-04-27

Plain-language summary

Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy, non-smoking, male and female subjects, 18 years of age or older.
. BMI ≥ 18.5 and 30.0 kg/m2
. No clinically significant findings in vital signs measurements.
. No clinically significant abnormal laboratory values.
. No clinically significant findings in a 12-lead electrocardiogram (ECG).
. No significant diseases.
. Willing to use an acceptable, effective method of contraception.
. Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion criteria

. Known history or presence of any clinically significant medical condition.
. Known or suspected carcinoma.
. History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or gastrointestinal ulcer, perforation, or haemorrhage.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively

Timeframe: 7 days (± 3 hours)

maximum serum concentration of ibuprofen and pseudoephedrine, respectively

Timeframe: 7 days (± 3 hours)

Trial details

NCT IDNCT03429738

SponsorInstitut für Pharmakologie und Präventive Medizin

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2014-05-05

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