January 31, 2014

TGP reveals results of human clinical study done on TGP Paracetamol

With more people looking for better and more affordable alternatives to quality healthcare, the country’s largest drugstore chain, The Generics Pharmacy® (TGP), continues to provide its customers with generic medicines that are equally safe and effective as off-patent branded medicines.
One example is the TGP Paracetamol. In a recent human clinical study conducted by the Center of Biopharmaceutical Research at the De La Salle Health Sciences Institute (DLSHSI), it was found that the TGP Paracetamol, the company’s first private label generic medicine, is as safe and effective as the leading and innovator paracetamol brands in the market. 

A human clinical study is a particular kind of research that is usually done by pharmaceutical companies to assess the safety and efficacy of a new drug. The TGP Paracetamol prides itself as the only clinical and human trial-tested private label paracetamol that is proven to be in equal effectiveness to off-patent brands.

Led by Director for Research Support and Extension Services, and Chairman of the Bioavailability Unit and Drug Testing Laboratory at DLSHSI, Dr. Rita Grace Alvero, the team tested the rate and extent of absorption of the TGP Paracetamol after single dose administration against the leading and innovator brands. 

The team’s study made use of a randomized three-way crossover single dosed bioequivalence study. A bioequivalence study is the objective way of measuring absorption in the body while a three-way crossover entails that one subject had to take the three drugs in different dates or intervals. 

“We are not measuring the clinical effects; we are more focused on the quantitative analysis of the TGP Paracetamol. This includes monitoring the safety and tolerability of the three drugs,” explained Dr. Alvero during the study presentation.

“Our study design was a standard one and it is in accordance with the guidelines of the FDA and European Medicines Agency (EMEA).”

After a three-month period, results of the study revealed that the parameters involved in the evaluation of the TGP Paracetamol were more or less similar to the other two drugs. 

“The final check of bioequivalence depends on the confidence interval. In this case, the TGP Paracetamol falls between the limit of acceptance which is 80-125. Thus, we can say that the TGP Paracetamol is bioequivalent or has the same clinical effects of the leading and innovator paracetamol brands,” added Dr. Alvero. 

The study also proves that the TGP Paracetamol and the two other drugs are therapeutically equivalent. All three are well tolerated and have the same formulation and safety profile, proving that TGP Paracetamol is as safe and effective to use as other brands yet more affordable with a price of only P1.00 per tablet. 

With over 1,600 outlets nationwide, TGP is the country’s largest drugstore chain. The company offers its customers a wide range of safe, effective and affordable generic medicines like vitamins, treatment for colds and cough, and maintenance medicines for the heart, diabetes and cholesterol. 

Customers can also get free medical consultation by availing of TGP’s Dial-A-Doc service via the number 732-3333. The service is available from Mondays to Saturdays, from 8:30 AM to 5:30 PM.

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