What is Phase I? Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of
testing. What
is Bioavailability? Bioavailability refers to the relative amount of drug from an administered dosage form which enters the systemic circulation and the rate at which the drug appears in the systemic circulation. What
is Bioequivalence? Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose. Phase-I
services include:
|
|
BA/BE.
|
|
|
Food
effect.
|
|
|
Steady
state.
|
|
|
Dose
response.
|
|
|
Special
populations.
|
|
|
Drug-drug
interaction.
|
|
|
Dose
escalations.
|
Clintrac has 40 bedded GCP compliant clinical facility capable of undertaking
each of the above variety of clinical studies. Clintrac conducts BA/BE studies as per ICH-GCP, CDSCO and other applicable guidelines. We are specialized in conducting BA/BE under fed and fasting conditions as well as steady state PK studies. Our facility also consists subject housing, independent dosing area, sample collection/processing, well equipped ICU, pantry and recreation hall.
Our experienced staff and well qualified investigators ensure that the trial
is conducted in a scientific and compliant manner, ensuring the safety and well being of the study subjects. Our clinical team has vast
experience with qualified investigators to ensure the subject rights, safety and well being is protected.
more.....
| 
