- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01830309
Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects
- Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.
Secondary
- To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)
- To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
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Seoul, Korea, Republiken av
- Asan Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male volunteers in the age between 20 and 45 years old(inclusive)
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)
- 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
- 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
- 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
- Understand the requirements of the study and voluntarily consent to participate in the study
Exclusion Criteria:
Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
The following criteria will be applied ONLY to PD/PK group
- H.pylori positive, as determined by the urea breath test
- Urine cotinine test positive
- Subject who were unable to be applicable for pH meter catheter
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sequence 1
Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition
|
Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
Andra namn:
|
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Experimentell: Sequence 2
Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition
|
Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Geometric mean ratio and 90% CI for log-transformed AUClast
Tidsram: Blood sampling during 24 or 48 hrs after administration
|
Blood sampling during 24 or 48 hrs after administration
|
|
Geometric mean ratio and 90% CI for log-transformed Cmax
Tidsram: Blood sampling during 24 or 48 hrs after administration
|
Blood sampling during 24 or 48 hrs after administration
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
time pH > 4
Tidsram: 24 hour before and after IP administration
|
24 hour before and after IP administration
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kyun-Seop Bae, MD, Ph.D, Asan Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CJ_APA_102
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