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Inhibitory effect of intravenous lansoprazole and pantoprazole on intragastric acidity in healthy Chinese volunteers: a randomized, open-labeled, two-way crossover study

Inhibitory effect of intravenous lansoprazole and pantoprazole on intragastric acidity in healthy Chinese volunteers: a randomized, open-labeled, two-way crossover study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001001
Enrollment
Unknown
Registered
2010-09-06
Start date
2009-02-25
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Group A:Lansoprazole at 30 mg IV at 8:00 and 20:00 each day for continous 5 days, followed by at least a 14-day washout interval, then with pantoprazole at 40 mg IV at 8:00 and 20:00 each day for cont

Sponsors

Changhai hospital, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male and female Chinese healthy volunteers from Han population aged 18 to 45 years old; 2. Helicobacter pylori negative; 3. body mass index between 19-24 kg/m2; 4. Signed informed consent; 5. Physical examination and lab tests normal.

Exclusion criteria

Exclusion criteria: 1. With a history of severe diseases within 2 weeks and received drugs which influence liver P450 enzymes; 2. With severe cardiovascular, respiratory, renal, liver and gastrointestinal diseases; 3. Pregnant or breast-feeding women; 4. Concomintant intake of drugs which influence P450 enzymes or gastric acidity; 5. With a history of attendance in any other trial within 12 weeks; 6. With alcoholism or drug abuse; 7. With a history of allergy to the study drugs or severe allergy diseases; 8. Smokers or other nicotine takers; 9. Designers or executive peoples of the trial.

Design outcomes

Primary

MeasureTime frame
The mean intragastric pH values on day 1;percentages of time with intragastric pH>4 and pH>6 on day 1 and 5;

Secondary

MeasureTime frame
mean and median pH on day 1 and 5, mean ph value each hour, percentages of time with intragastric pH;

Countries

China

Contacts

Public ContactZhaoshen Li
zhsli@81890.net+86 21 81873241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026