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NCT03851341
Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers
Phase 1 trial testing Janumet XR tablet 100/1000 mg in Healthy in 30 participants. Completed in 18 January 2019.
12 January 2019
Quick facts
| Lead sponsor | GL Pharm Tech Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 2 January 2019 |
| Primary completion | 12 January 2019 |
| Estimated completion | 18 January 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Janumet XR tablet 100/1000 mg
- GLH1SM tablet 100/1000 mg
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
GL Pharm Tech Corporation — full company profile →
Who can join
19 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fasting condition
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fc Gamma Receptors as Regulators of Bone Destruction in Inflammatory Arthritis.
Zuo Y, Deng GM. · · 2021 · cited 23× · PMID 34248975 · DOI 10.3389/fimmu.2021.688201
Verify or expand the search:
- PubMed search for NCT03851341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Janumet XR tablet 100/1000 mg
Trials testing the same drug.
- NCT03927170 — Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed) · Phase 1 · completed
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Other GL Pharm Tech Corporation trials
Trials by the same sponsor.
- NCT04679883 — Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease · Phase 2 · unknown
- NCT04104997 — A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mu · Phase 1 · completed
- NCT03963362 — The Pharmacokinetics of GLA5PR Tablet According to the Renal Function · Phase 1 · unknown
- NCT03927170 — Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed) · Phase 1 · 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 NCT03851341 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GL Pharm Tech Corporation
- Last refreshed: 24 April 2019
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/NCT03851341.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing