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NCT07161180: PBK_M2301_BE
Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Phase 1 trial testing PBK_M2301 (levodropropizine + Pelargonium sidoides extract) in Healthy Volunteers in 32 participants. Currently enrolling.
30 October 2025
Quick facts
| Lead sponsor | Pharmbio Korea Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 27 August 2025 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 November 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- PBK_M2301 (levodropropizine + Pelargonium sidoides extract) — full drug profile →
- R1_PBK_M2301 (levodropropizine) — full drug profile →
- R2_PBK_M2301 (Pelargonium sidoides extract) — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Pharmbio Korea Co., Ltd. — full company profile →
Who can join
Adults 19 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this Phase 1 clinical trial is to evaluate the safety and pharmacokinetic characteristics of PBK\_M2301 in healthy adult volunteers. The main questions it aims to answer are: What are the maximum concentration (Cmax) and total drug exposure (AUCt) of PBK\_M2301 compared to the combination of two reference drugs? Are there any safety concerns associated with a single oral dose of PBK\_M2301? Researchers will compare PBK\_M2301 with the combination of R1\_PBK\_M2301 and R2\_PBK\_M2301 to assess differences in drug levels. Participants will: Receive each treatment once in a randomized sequence with a one-week washout in between Provide blood samples at multiple time points after dosing Undergo safety assessments including adverse event monitoring, vital signs, laboratory tests, and ECGs
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07161180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pharmbio Korea Co., Ltd. trials
Trials by the same sponsor.
- NCT07017335 — Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults · Phase 1 · completed
- NCT05509868 — Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea · Phase 3 · completed
- NCT04418388 — Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women · Phase 1 · completed
- NCT03509220 — Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07161180 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharmbio Korea Co., Ltd.
- Last refreshed: 12 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07161180.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing