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CompletedNCT04467060Updated Jul 10, 2020

A Single Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects

A Phase 1 interventional study of Anaprazole Sodium and Placebo in Healthy Male Volunteers, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-10.

Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 10 months after the study started (first participant enrolled Aug 2014, registered Jun 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.

02

Conditions studied

  • Healthy Male Volunteers
03

In context

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily;
  2. The subject is a Chinese health adult, aged 18 to 45 years, inclusive;
  3. The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m\^2 and 25.0 kg/m\^2, inclusive;
  4. Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion
  5. No medical history of allergy to proton pump inhibitors and no any other drug allergy history;
  6. The subjects have a good lifestyle and can keep good communication with the investigators and comply with the requirements of clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc), liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or medical history of any other system (cardiovascular, respiratory, psychoneural, hematology, endocrinology and etc) ;
  2. Has clinical significant abnormal electrolytes (especially hypopotassemia) in screening examination;
  3. Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings);
  4. Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal nasal septum;
  5. With positive result of drug screening test;
  6. With positive result of nicotine test;
  7. Female participants who are pregnant, breast-feeding or menstral period, or participants has no effective contraception method, or has pregnancy plan in 6 months;
  8. Has received any drugs: acid-inhibitors, any priscription drug, herb medicine, non-prescription drugs and/or food suppliments (including vitamine) within 2 weeks before randomization;
  9. Blood donation / blood loss ≥400 mL within 3 months, or participated any other clinical trials within 3 months;
  10. Known Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;
  11. Frequent alcoholics (drink more than 2 units of alcohol per day, 1 unit = 330 mL beer or 25 mL liquor or 125 mL wine), or took food or drinks with alcoholics 72 hours before randomization;
  12. Has taken foods or drinks with xanthine(cafeine) or intensive excercise. Has taken foods or drinks that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 14 days before administration of investigational drugs;
  13. Smoke more than 5 pieces per week;
  14. Any conditions in which considered by investigator not be appropriate to participate in this trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Anaprazole Sodium enteric-coated tablet

    Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration.

    Drug: Anaprazole Sodium

  • Placebo comparator
    Placebo

    single dose, fasting oral administration

    Drug: Placebo

Interventions

  • DrugAnaprazole Sodium

    2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg,fasting oral administration.

  • DrugPlacebo

    single dose, fasting oral administration

06

What researchers measure

Primary outcomes

  1. Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0

    All adverse events will be monitored in each subject

    Time frame: From signing informed consent to study completion, 8 days post-dose

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04467060
Lead sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
Responsible party
Sponsor
First posted
Jul 10, 2020
Start date
Aug 14, 2014
Primary completion
Jun 25, 2015
Completion
Jun 25, 2015
Last update
Jul 10, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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