Cough drug combo under microscope: will they mix safely?
NCT ID NCT07017335
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed Phase 1 trial looked at how two drugs—levocloperastine (a cough suppressant) and Pelargonium sidoides extract (a herbal remedy often used for colds)—affect each other when taken together. Twenty-four healthy adults took each drug alone and then together, and researchers measured drug levels in their blood. The goal was to see if combining them changes how the body processes either drug, which is important for future combination treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Levocloperastine and Pelargonium sidoides extract
- What this could lead to
- If successful, this study could show that these two drugs can be safely combined, potentially leading to a more effective cough or cold treatment.
- What could go wrong
- This is a very early Phase 1 trial with only 24 healthy volunteers, not patients. It only checks how the drugs interact in the body, not whether they work for any illness. Results may not apply to sick people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\<Inclusion Criteria\> 1. Healthy male or female adults aged ≥19 and \<65 years at the time of screening. 2. Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height² \[m²\]); * Male participants must weigh at least 50 kg. * Female participants must weigh at least 45 kg. 3. No clinically significant congenital or chronic diseases, and no abnormal findings from a medical examination (e.g., electroencephalogram, electrocardiogram, chest and/or gastrointestinal endoscopy, or radiologic examinations, if deemed necessary). 4. Laboratory test results (including hematology, clinical chemistry, coagulation tests, serology, urinalysis) and ECG results deemed suitable for study participation by the investigator (or sub-investigator). 5. Willing and able to voluntarily provide written informed consent after receiving detailed information about the study, and agrees to comply with study requirements. 6. Agrees to use medically accepted contraception methods\* from the first administration of the investigational product through 1 week after the final administration, and agrees not to donate sperm or ova during this period. * Medically accepted contraception includes intrauterine devices (IUD, IUS), sterilization (vasectomy or tubal ligation), or combination of barrier methods (e.g., male/female condoms, cervical caps, diaphragms, sponges), possibly with spermicide. \<Exclusion criteria\> 1. Use of enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 30 days prior to the first dose, or use of any medication that may interfere with the study within 10 days prior to the first dose. 2. Participation in another clinical trial involving administration of an investigational drug or bioequivalence study within 6 months prior to the first dose. 3. Donation of whole blood within 8 weeks, donation of blood components within 2 weeks, or receipt of blood transfusion within 4 weeks prior to the first dose. 4. History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair). 5. Within 1 month prior to the first dose, meets one of the following: * Alcohol consumption \>21 drinks/week (males) or \>14 drinks/week (females); (1 drink = 50 mL soju, 250 mL beer, or 30 mL whiskey) * Smoking \>20 cigarettes/day on average. 6. Individuals with any of the following conditions: * Known hypersensitivity to the investigational product or its components * Increased bronchial mucus secretion * Mucociliary dysfunction (e.g., Kartagener syndrome, primary ciliary dyskinesia) * Bleeding tendency or use of anticoagulants * Severe hepatic impairment * Severe liver or kidney disease * Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 7. History of clinically significant psychiatric illness. 8. Any other condition deemed by the principal investigator (or sub-investigator) to render the subject unsuitable for study participation. 9. Female participants who are pregnant, suspected of being pregnant, or breastfeeding.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Drug-drug interaction healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
H+ Yangji Hospital
Seoul, Seoul, 08799, South Korea