Clinical trial NCT01045434: Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions
Official title: Open Label, Balanced, Randomized, Two-treatment,Two-period,Single-dose, Cross-over Oral Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule With Prilosec® OTCTM 20 mg Tablets in Healthy Human Adult Subjects, Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
omeprazole
crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed conditions.

Detailed description: This study used a crossover design consisting of 2 treatments, 2 sequences and 2 periods. Study Period-I and IT were separated by a washout period of 14 days. Use of a crossover design is appropriate since it enables comparison of treatments within the same subject using intrasubject variability thus improving the precision of treatment comparisons. Also use of 14 days of washout period between successive drug administrations eliminates chances of residual drug being present at preceding period (i.e Period 1) to next period (i.e Period II).

Eligibility criteria: Inclusion Criteria:

* Healthy human subjects within the age range of 18 to 45 years.
* Non-smokers since at least six months.
* Willingness to provide written informed consent to participate in the study.
* Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg.
* Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
* Normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
* Normal chest X-ray PA view.
* Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
* 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, or
  * postmenopausal for at least 1 year, or
  * surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

* Personal/family history of allergy or hypersensitivity to Omeprazole or allied drugs.
* Past history of anaphylaxis or angioedema.
* Any major illness in the past three months or any clinically significant ongoing chronic medical illness .e.g. congestive heart failure, hepatitis, pancreatitis etc.
* Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
* Any cardiac, renal or liver impairment, any other organ or system impairment.
* History of seizure or psychiatric disorders.
* Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus
* Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study \[one drink is equal to one unit of alcohol \[one glass wine, half pint beer, and one measure (one ounce) of spirit\].
* Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period.
* Use of any recreational drug or a history of drug addiction.
* Participation in any clinical trial within the past 3 months.
* Inaccessibility of veins in left and right arm.
* Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication.
* Receipt of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks.
* An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and through out subject's participation in the study. Consumption of grapefruit-containing food or beverages within 7 days prior to receiving the first dose of study medication in both the periods Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC parameters
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Wellquest Clinical Research
state: Maharashtra
Study officials:
affiliation: Wellquest Clinical Research
name: Dr Ghanashyam Rao, MBBS
role: PRINCIPAL_INVESTIGATOR
References: