Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions

NCT01270308 | Completed Phase 1

• 1 other identifier: P-699/08
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.

Conditions

Healthy

Keywords

Bioequivalence; two way crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  4 months

Study Arms (2)

Lansoprazole DR Capsules 30 mg

EXPERIMENTAL

Lansoprazole DR Capsules 30 mg of Dr.Reddy's Laboratories Limited

Drug: Lansoprazole

Prevacid 30 mg Capsules

ACTIVE COMPARATOR

Prevacid 30 mg Capsules of TAP Pharmaceuticals Inc. USA

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

Lansoprazole DR Capsules 30 mg

Also known as: Prevacid

Lansoprazole DR Capsules 30 mg; Prevacid 30 mg Capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• i. Provided written informed consent.
• ii. Subject who were healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
• iii. Subject having a body mass index between 18.0 and 29.9 (both inclusive), calculated as weight in Kg/height in m2.
• iv. Subject having a normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician /investigator to be of no clinical significance).
• v. Female Subjects 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.
• postmenopausal for at least 1 year.
• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

You may not qualify if:

• i. Subject who were incapable of understanding the informed consent.
• ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
• iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
• iv. Oral temperature is below 95.0°F or above 98.6°F.
• v. Pulse rate below 50/min or above 100/min.
• vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
• vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period.
• ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
• x. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
• xi. Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
• xii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
• xiii. Clinically significant abnormalities and / or with significant diseases.
• xiv. Confirmed positive in alcohol screening.
• xv. Confirmed positive in selected drug of abuse.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research (P) Ltd

Bālānagar, Hyderabad, 500 037, India

Location

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr.M.Venkat Jayanth, MBBS

  Bioserve Clinical Research (P) Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: December 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 5, 2011

Record last verified: 2009-02

Locations

IN (1)