PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses

What Was Tested

The trial (phase 1) is built around L-Carnitine.

It had 1 arm (groups): Single arm (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 19 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Sex: Male and female of same proportion. Healthy individuals. Age: 19 to 45. Similar age. Weight: All subjects need to weigh ≥50 kg. BMI within 19\~24 kg/m2. Similar weight between subjects.；. Blood pressure: SBP 90-139mmHg，DBP 60-89 mmHg；. Subjects need to understand and agree before the start of trial and signed the informed consent form.

The full record lists 6 inclusion and 34 exclusion criteria; among the exclusions: hepatitis b surface antigen positive;; hepatitis c antibody positive;; HIV, Syphilis positive;.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the L-Carnitine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-06 with completion listed for 2015-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under Curve (AUC) (time frame: Day 3 and 4, 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after drug administration on day 5).

It also tracked 1 secondary outcome, for example cumulative urine excretion rate.

What This Means in Plain Language

Put simply, this is a phase 1 trial of L-Carnitine in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.