Clinical trials: Fasting Conditions
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol…
- Trial name
- NCT05300087
- Testing
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions
- Trial name
- NCT03512808
- Testing
- Ursodiol 500 MG, Urso Forte 500Mg Tablet
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Fasting
Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the…
- Trial name
- NCT01503398
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.
- Trial name
- NCT05954247
- Testing
- DWJ1543, DWC202216
- Volunteers
- 24 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Relative Bioavailability
A Relative Bioavailability Study With a Novel PanCytoVir™ Oral Suspension (100 mg/ml)
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100 mg/mL) versus probenecid 500 mg tablets in…
- Trial name
- NCT06025344
- Testing
- PanCytoVir™ 100 mg/mL oral suspension, Probenecid 500 mg
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- TrippBio, Inc.
Ovarian Cancer, Breast Cancer
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
- Trial name
- NCT05258747
- Testing
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Sandoz
Male Hypogonadism
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed…
- Trial name
- NCT02966652
- Testing
- DITEST, Testosterone undecanoate
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Neurocrine UK Limited
Therapeutic Equivalency
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under…
- Trial name
- NCT00684762
- Testing
- Cilostazol 100 mg Tablets, Cilostazol (Pletal®) 100 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions
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…
- Trial name
- NCT00776646
- Testing
- hydrochlorothiazide 50 mg tablet
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioavailability
Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.
- Trial name
- NCT00800475
- Testing
- Gemfibrozil Tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Blu Caribe
Diabetes Mellitus (Type 2)
A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions
This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult…
- Trial name
- NCT07548957
- Testing
- Administration of UI087, Administration of UIC202506, UIC202507, UIC202508
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Healthy
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim…
- Trial name
- NCT01936012
- Testing
- Lisinopril 10 mg tablets of PT Dexa Medica, Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Drug Drug Interaction
Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug)
An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover oral drug-drug interaction study of spironolactone (perpetrator) and Digoxin (substrate drug) in healthy adult human subjects…
- Trial name
- NCT03909529
- Testing
- Digoxin 250 MCG Oral Tablet, Spironolactone 25 mg/ 5 mL S/F Suspension
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CMP Development, LLC
Bioavailability
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.
- Trial name
- NCT01448772
- Testing
- Dronabinol Capsules, 5 mg, Dronabinol Oral Solution
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy
Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European Egyptian Pharmaceutical Industries, Egypt) versus…
- Trial name
- NCT02675127
- Testing
- Daktavira, Daklinza
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
- Trial name
- NCT00834977
- Testing
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Clostridium Difficile Infection (CDI)
Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics
Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer…
- Trial name
- NCT07251127
- Testing
- Delayed-release metronidazole, Immediate-release metronidazole
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Gateway Pharmaceutical LLC
Healthy
A Relative Bioavailability Study of Alprazolam 3 mg Extended Release Tablets Under Non-fasting Conditions
The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3…
- Trial name
- NCT00865657
- Testing
- Alprazolam 3 mg Extended Release Tablets, single dose, XANAX XR® 3 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
The objective of this study was to compare the relative bioavailability of zafirlukast tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy, adult, human, subjects under fasting conditions…
- Trial name
- NCT01283061
- Testing
- Zafirlukast
- Where
- India
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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