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CompletedNCT01283919Updated Jan 26, 2011

Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition

A Phase 1 interventional study of Pantoprazole Sodium in Fasting, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-26.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.

Read the detailed description

This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.

02

Conditions studied

  • Fasting
03

In context

Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  1. Subjects will provide written informed consent.
  2. Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
  3. Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
  4. Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study.
  5. Have normal EcG, X-ray and vital signs.
  6. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  7. If subject is a female volunteer and

    1. Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
    2. is postmenopausal for at least 1 year.
    3. is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion criteria

Exclusion Criteria:

  1. Subjects incapable of understanding the informed consent.
  2. Subjects with BP≤90/60 or BP≥140/90
  3. History of hypersensitivity or idiosyncratic reaction to pantoprazole or other proton pump inhibitors.
  4. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  5. Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
  6. Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical period.
  7. History of any psychiatric illness, which may impair the ability to provide written, informed consent.
  8. Subjects who have a history of alcohol or substance abuse within the last 5 years.
  9. Subjects with clinically significant abnormal values of laboratory parameters.
  10. Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
  11. Subjects with positive urine screen for drugs of abuse.
  12. Any subject in whom pantoprazole is contraindicated for medical reasons.
  13. Female volunteers demonstrating a positive pregnancy screen.
  14. Female volunteers who are currently breast-feeding.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Pantoprazole Sodium

    Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited

    Drug: Pantoprazole Sodium

  • Active comparator
    Protonix

    Protonix 40 mg DR Tablets of Wyeth Laboratories

    Drug: Pantoprazole Sodium

Interventions

  • DrugPantoprazole Sodium

    Pantoprazole Sodium DR Tablets 40 mg

    Also known as: Protonix DR Tablets 40 mg

06

What researchers measure

Primary outcomes

  1. Bioequivalence on Cmax and AUC parameters

    Time frame: 2 months

07

Study locations

1 site
  • VimtaLabsLtd.
    Hyderabad, Andhrapradesh 500 051, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01283919
Lead sponsor
Dr. Reddy's Laboratories Limited
First posted
Jan 26, 2011
Start date
Oct 2004
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Jan 26, 2011

Study contacts

Mangesh Kulkarni, M.D
principal investigator · VimtaLabsLtd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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