Frequently Asked Questions

An Informed Consent Form is a document that contains information about the research study such as the purpose of the study, the procedures, what study drugs will be given to you, the benefits, the stipend, and the risks. Informed consent is a continuous process, and you will have the opportunity to ask the study staff or study doctor any questions or concerns you may have before signing the document. Until you voluntarily signed the consent form, no tests or procedures can be performed.

Pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and they display comparable bioavailability, when studied under similar experimental conditions. Bioequivalence is considered proven, in case the bioavailability, in terms of peak (Cmax and Tmax) and total exposure (area under the curve (AUC)) after administration of the same molar dose under the same conditions, are similar to such a degree that the effects of the studied products can be expected to be essentially the same.

Bioavailability is the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body. Bioavailability can be influenced by inactive ingredients in the drug such as additives that prevent the medication from dissolving in the stomach.

Placebo is made of inactive substances and it is designed to look the same and can be packaged the same as the investigational drug.

A fed study is a study that requires you to eat a standardized high calorie, high fat breakfast.

Each study may require fasting between 8 to 12 hours. The study staff will inform you of this should it be required during the informed consenting process and during the study.

Standard meals and snacks will be provided during your stay.

You are expected to follow the study requirements and clinic rules during your participation in a research study.

There is no guarantee that you will benefit from your participation in this study. However, information learned from the study may help other people in the future.

These include but not limited to undergarments, pants, shirts, socks, jacket, sweatshirt, pajamas, closed toe shoes with protective soles, travel size toothpaste, toothbrush, soap, shampoo, feminine hygiene products and non-aerosol deodorant and laundry soap in its original container.

These include but not limited to food, beverages or snacks, gum, candy including mints, cough drops or lozenges, alcohol containing products such as mouthwash, colognes or perfumes, caffeine containing products, tobacco products, blankets, pillows, offensive or revealing clothing, non-approved medications or over the counter medications, herbal or dietary supplements.

You will be paid for participating in a research study. If you do not finish the entire study, you will be paid for the visits that you completed.