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NCT02500485
Drug Interaction Study of Henagliflozin and Retagliptin in Healthy Subjects
Phase 1 trial testing SHR3824, SP2086 in Type 2 Diabetes in 12 participants. Status unknown.
1 July 2015
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 May 2015 |
| Primary completion | 1 July 2015 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR3824, SP2086 — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, male only, with Type 2 Diabetes. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The maximum plasma concentration (Cmax) of SHR3824.
Time frame: At protocol-specified times up to Day 14 and Day 18.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086. -
The area under the plasma concentration-time curve (AUC) of SHR3824.
Time frame: At protocol-specified times up to Day 14 and Day 18.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086. -
The maximum plasma concentration (Cmax) of SP2086.
Time frame: At protocol-specified times up to Day 4 and Day 18.
Cmax (a measure of the body's exposure to SP2086) will be compared. before and after administration of multiple doses of SHR3824 -
The area under the plasma concentration-time curve (AUC) of SP2086.
Time frame: At protocol-specified times up to Day 4 and Day 18.
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824. -
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: Up tp day 18.
Sponsor's own description
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02500485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · 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 NCT02500485 (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 Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 23 November 2015
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