Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions

NCT00776646 | Completed DMC

• 1 other identifier: 107_HYDRO¬_06
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition

Conditions

Healthy

Keywords

bioequivalence hydrochlorothiazide 50 mg tablet fasting conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

hydrochlorothiazide 50 mg tablet

Drug: hydrochlorothiazide 50 mg tablet

2

ACTIVE COMPARATOR

hydrochlorothiazide 50 mg tablet

Drug: hydrochlorothiazide 50 mg tablet

Interventions

hydrochlorothiazide 50 mg tablet DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• Aged 18-45 years.
• Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Had voluntarily given written informed consent to participate in this study.
• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

You may not qualify if:

• \- Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs.
• Had history of diarrhoea, vomiting or headache within past two weeks
• Had history of hypotension (systolic BP\<100 mmHg)
• Had history of allergy or bronchial asthma
• Had history of muscle cramps or muscle weakness
• Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE)
• Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia
• Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis.
• Had history of erythema multiforme including Stevens- Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis
• Had history of pancreatitis
• Had history/evidence of jaundice or any hepatic or gall bladder disease
• Had history of hyperglycemia, glycosuria, hyperuricemia or gout.
• The subject had a history/evidence of any electrolyte imbalance, serum sodium \< 135 mEq/L, serum potassium \< 3.5 mEq/ L.
• Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead
• IPCA Laboratories Ltd.: collaborator

Related Links

• Related Info
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MeSH Terms

Interventions

Hydrochlorothiazide; Tablets

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: May 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: August 1, 2006
• Last Updated: October 21, 2008

Record last verified: 2008-10