BACKGROUND AND OBJECTIVES

Pelargonium sidoides DC. Root (PELARGO) 20 mg capsule is approved by the Philippine Food and Drug Administration (FDA) for the symptomatic treatment of common cold. In compliance with FDA, this post-authorization safety study was conducted to determine the incidence of signs and symptoms of liver injury with PELARGO intake. It also aimed to look at symptom improvement and the incidence of other adverse events.

METHODS

This non-interventional post-authorization safety study enrolled 300 adult patients with common cold, pre- scribed with Pelargonium sidoides DC. 20 mg capsule three times a day for seven days during routine clinical care from May 2023 to December 2023 in Cavite, Philippines. Demographic, clinical, and physical exam data were collected at baseline. Physical exam data, signs and symptoms of liver injury, symptom improvement, and other adverse events were determined post-treatment. Descriptive statistics were computed to characterize the participants at baseline (day 0) and end-study visit (day 8).

RESULTS

There were 300 enrolled patients, 53% female and 60% single. The mean age was 36 years and the mean BMI was 26 kg/m2. Vital signs at baseline were mostly within normal limits and most had respiratory f indings. Two hundred ninety-eight (298) completed the study. Only a few had respiratory findings at end-study visit. There were no signs and symptoms of liver toxicity nor serious adverse events after seven days of PELARGO intake. Reported adverse effects with 2.0% to 1.3% incidence in seven days include dizziness, drowsiness, headache, and polyphagia. Others wereCONCLUSION

There is no evidence of liver toxicity after seven days of PELARGO intake for common cold among Filipino adults. The drug was well tolerated, and most patients experienced significant symptom improvement. Results should be interpreted with caution in the light of study limitations.

Human ; Pelargonium ; Common Cold

Objectives: Bioequivalence studies provide evidence that generic drugs can produce the same blood levels as the innovator, suggesting similar efficacy and safety and indicating interchangeability without the need to titrate dosing. This study aimed to compare the rate and extent of absorption of two simvastatin 20 mg tablets of Pascual Laboratories, Inc. with two Zocor 20 mg tablets of Merck Sharp & Dohme (I.A.) Corp. in healthy Filipinos. The study also monitored the safety and tolerability of the medications, under the same conditions. Proof of bioequivalence is required by FDA Philippines to establish the interchangeability of generic products and their innovators. Methods: Twenty-four healthy participants were administered with a single oral dose of two 20 mg simvastatin tablets under fasting conditions, in a randomized, open-label, blind-endpoint analysis, two-way crossover study, with a washout period of one week. Pharmacokinetic blood sampling was done up to 24 h post-dose. Simvastatin was measured using Liquid Chromatography-Tandem Mass Spectrometry with a validated method. The geometric mean ratios for maximum plasma concentration (Cmax) and area under the plasma-concentration-time curve from time zero to the last observed concentration at time 24 h (AUC0-24) were used for bioequivalence. Results: All 24 participants, 12 males and 12 females, completed the study. Mean age was 24.21 years, mean weight was 58.81 kg, and mean BMI was 23.16 kg/m2. The ratios of Cmax and AUC0-24 were 102.17% (90% CI: 89.19-117.03), and 101.29% (90% CI: 86.87-118.10), respectively, and were both within the bioequivalence limits of 80% to 125%. No adverse event was reported and both formulations were well-tolerated. Conclusions Simvastatin 20 mg tablet of Pascual Laboratories, Inc. and the innovator Zocor 20 mg tablet are bioequivalent. Single two-tablet doses of both products are safe and well tolerated.
Simvastatin ; Hydroxymethylglutaryl-CoA Reductase Inhibitors