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NCT06768619
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
NA trial testing Group 1: single-dose of test formulation+single-dose of reference formulation in Thrombocytopenia in 36 participants. Completed in 27 April 2023.
27 April 2023
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 20 March 2023 |
| Primary completion | 27 April 2023 |
| Estimated completion | 27 April 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Group 1: single-dose of test formulation+single-dose of reference formulation — full drug profile →
- Group 2: single-dose of reference formulation+single-dose of test formulation — full drug profile →
Conditions studied
- Thrombocytopenia — all drugs for Thrombocytopenia →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Evaluate the human bioequivalence of single dose Reference Listed Drug (RLD) after meals, providing reference for clinical evaluation and medication use.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Single-Center, Randomized, Open-Label, Two-Formulation, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of Two Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State.
Wu K, Ren Q, Wang Y, Zhou Y, et al · · 2026 · PMID 41653397 · DOI 10.1007/s40261-026-01528-0
Verify or expand the search:
- PubMed search for NCT06768619
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Group 1: single-dose of test formulation+single-dose of reference formulation
Trials testing the same drug.
- NCT06768632 — Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State · NA · completed
Other recruiting trials for Thrombocytopenia
Currently open trials in the same condition.
- NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
- NCT07442513 — Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT · Phase 3 · recruiting
- NCT07257809 — Herombopag Treated T-DM1 Induced Platelet Reduction · Phase 2 · recruiting
- NCT06676904 — Neonatal Platelet Transfusion Threshold Trial · NA · recruiting
- NCT06886516 — Apixaban in Thrombocytopenia · EARLY_PHASE1 · recruiting
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · 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 NCT06768619 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 16 December 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/NCT06768619.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing