- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02815787
The Drug -Drug Interaction of SP2086 and Glyburide
23. Juni 2016 aktualisiert von: Jiangsu HengRui Medicine Co., Ltd.
A Single Randomized, Open, Cross-over, Phase Ie Study to Access the Drug-drug Interaction of SP2086 and Glyburide
The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers.
All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
16
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself.
Exclusion Criteria:
- Have the abnormal lab or other examination results and the change have clinical significance.
- Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
- History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
- History of severe unconsciousness hypoglycemia
- History of any surgery prior to screening in 6 months.
- History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
- History of participate any drug or medical device prior to screening in 3 months.
- Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
- 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
- The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: SP2086 and Glyburide
The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days.
In this group,the subjects was given the drugs from A sequence to the B sequence.
|
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
|
Aktiver Komparator: Glyburide and SP2086
The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days.In this group,the subjects was given the drugs from B sequence to the A sequence.
|
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The maximum plasma concentration (Cmax) of SP2086
Zeitfenster: up to Day 25
|
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
|
up to Day 25
|
The maximum plasma concentration (Cmax) of SP2086 acid
Zeitfenster: up to Day 25
|
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
|
up to Day 25
|
The maximum plasma concentration (Cmax) of Glyburide
Zeitfenster: up to Day 25
|
Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
|
up to Day 25
|
The area under the plasma concentration-time curve (AUC) of SP2086
Zeitfenster: up to Day 25
|
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
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up to Day 25
|
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Zeitfenster: up to Day 25
|
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
|
up to Day 25
|
The area under the plasma concentration-time curve (AUC) of Glyburide
Zeitfenster: up to Day 25
|
AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
|
up to Day 25
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
The number of volunteers with adverse events as a measure of safety and tolerability
Zeitfenster: up to Day 25
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up to Day 25
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: RuiChen Guo, M.D, Qilu Hospital of Shandong University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2014
Primärer Abschluss (Tatsächlich)
1. Juli 2014
Studienabschluss (Tatsächlich)
1. Juli 2014
Studienanmeldedaten
Zuerst eingereicht
3. Januar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. Juni 2016
Zuerst gepostet (Schätzen)
28. Juni 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
28. Juni 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Juni 2016
Zuletzt verifiziert
1. Juni 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QLHCPI-179
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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