Clinical trials: Therapeutic Equivalency
Healthy
Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fed conditions.
- Trial name
- NCT00648154
- Testing
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04406194)
- Testing
- FAVICOVIR 200 mg Film Tablet, AVIGAN 200 mg Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Healthy Participants
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system…
- Trial name
- NCT07214766
- Testing
- Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules…
- Trial name
- NCT00759954
- Testing
- morphine sulfate sustained-release capsules, KADIAN (morphine sulfate sustained-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalence
The Bioequivalence Study of Umifenovir 200 mg Capsul (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride and a single dose of Test product containing 200 mg umifenovir hydrochloride monohydrate…
- Trial name
- Umifenovir (NCT04476719)
- Testing
- ATAFENOVIR 200 MG KAPSUL, ARBIDOL 100 MG KAPSUL
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Thromboembolic Disorders
A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants
Researchers were looking for another way to treat people with a blood clot in their veins. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it behaves.
- Trial name
- NCT04720092
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral…
- Trial name
- NCT00853892
- Testing
- Controlled-Release Oxycodone Hydrochloride 40 mg tablet, OxyContin® 40 mg tablet
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy Vollunteer
Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy…
- Trial name
- BE24-005 (NCT06316336)
- Testing
- Alfuzosin Hydrochloride 10 mg, Xatral® XL 10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pharma Nueva
Healthy
Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT00829309
- Testing
- Pravastatin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers
The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.
- Trial name
- NCT05787873
- Testing
- SIPS-2209-1, SIPS-2209-2, SIPS-2209-3
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Samik Pharmaceutical Co. Ltd.
Antimycotic for Systematic Use
Evaluate Bioequivalence of Voriconazole(200mg/Vial) .
A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole in Healthy Volunteers Under Fasting Conditions.
- Trial name
- NCT04552353
- Testing
- Vaway
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy, Plasma Concentration of YM060
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake
A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.
- Trial name
- NCT01394653
- Testing
- YM060
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy
Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition
Objective: The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck \& Co., Inc.
- Trial name
- NCT01218022
- Testing
- Losartan Potassium Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Diabetes, Healthy
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between…
- Trial name
- NCT01766245
- Testing
- semaglutide
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
- Trial name
- NCT01581931
- Testing
- Linagliptin/metformin, Metformin, Linagliptin
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Multiple Sclerosis
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.
- Trial name
- NCT00913250
- Testing
- Serum containing Avonex, Serum Free Avonex
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Biogen
Benign Prostatic Hyperplasia
A Clinical Trial to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers
The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
- Trial name
- NCT07715305
- Testing
- AD-116A, AD-1161
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Healthy
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
- Trial name
- NCT05742594
- Testing
- Lazertinib
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects
The present study was conducted with the objective of comparing the bioequivalence and safety of a single dose of ranolazine extended-release tablets (Test product) manufactured by Haisco Pharmaceutical Group Co., Ltd.
- Trial name
- NCT07054255
- Testing
- Test formulation (Ranolazine extended-release tablets), Reference formulation (Ranolazine extended-release tablets)
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
- Trial name
- NCT01399788
- Testing
- Myrin P Forte, Single drug references
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
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